The Fusion of Superior Technologies. sagemax

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1 The Fusion of Superior Technologies ZIRCONIA / COLOR / PMMA / WAX sagemax

2 S : Highest Strength Dental Zirconia Coping Made of S p 4-Point bending strength > 1,500 MPa (ISO 13356:2008) p Biaxial flexural strength > 1,400 MPa (ISO 13356:2008) p 1-CR (%) Translucency: >30% (Thickness: 1.0mm) Stained by Zr Powered by Quality TM 02

3 Table of Contents About Sagemax 04 Made in USA 05 Materials 06 Clinical Study (The DENTAL ADVISOR Report) 07 Quality Management System Certifications (CE Mark, ISO 13485, 9001) 08 FDA 510K & IDENT Ceram 09 About NexxZr T -The Highest Translucency Dental Zirconia 10 About NexxZr S -The Highest Strength Dental Zirconia 11 About SagePMMA 12 D-98 Disc Product List 49 S-Blank Product List 57 K-Blank Product List 59 Contact 61 About SageWAX 13 About NexxZr COLOR 14 NexxZr Capability 15 Shapes and Sizes 16 W-98 Disc Product List 17 R-99 Disc Product List 25 Z-95 Disc Product List 33 A-71 Disc Product List 41 03

4 About Sagemax Based in the USA, Sagemax Bioceramics, Inc. is one of the largest manufacturers of dental zirconia in the world. Since our start in 2006, our customers have fabricated approximately 9 million zirconia restorations worldwide. Using the highest quality machines and zirconia powder, our production combines German engineering with processes from Japan to produce consistent high quality zirconia blanks. Sagemax zirconia is carefully monitored throughout production and our quality system ensures our product is inspected for perfection. Our Neighbors There are many great companies based in the surrounding neighborhoods of Seattle, Washington, USA. After moving into a new facility in 2012, we are now capable of producing over 15,000 discs per month and we are still expanding. The Sagemax network reaches worldwide. We have branch offices in Italy, Germany, Netherlands, Russia and Hong Kong. We have obtained international certifications such as CE mark, FDA 510K and the highest level certification for medical devices, ISO Sagemax Headquarters and Manufacturing Facility - 20,000 SF. Federal Way, WA, USA 04

5 Page Made Titlein USA At the Sagemax USA manufacturing Ffacility we perform the following processes: Pre-form Zirconia Powder. Cold Isostatic Pressing. Uniaxial Pressing. Cutting and Milling. Firing for Pre-sintering. Shrinkage Analysis & Quality Control. Quality Testing Packaging Foam Cutting. Packing, Labeling and Shipping. Customer Service and Training. 05

6 Materials cleared for use by the FDA as a medical device. T High translucency,non-shaded used for full contour and layering. High translucency, pre-shaded used for copings and hybrid layering. S High strength, non-shaded used for polychromatic layering of copings, bridges, and implant substructures. PMMA discs used to produce temporaries, available in various shades as well as white and clear. Machinable wax, blue used for full contour and copings, white for diagnostic presentations. Color pastes for pre-staining green state zirconia. 06

7 Clinical Study Sagemax NexxZr T earned an excellent 5 star rating from The Dental Advisor during a 6 month clinical evaluation. Independent In Vivo studies of 160 NexxZr T full contour restorations showed excellent results in all categories Results at 6 Months TM In December, 2012, 25 NexxZr T restorations were recalled and evaluated. TM recalled NexxZr T restorations were evaluated in the following categories Lack of sensitivity Esthetics Resistance to fracture/chipping Resistance to marginal discoloration Wear resistance of zirconia and opposing dentition Retention Esthetics, resistance to fracture or chipping, resistance to marginal discoloration, and wear resistance of the resoration and opposing dentition rated excellent Ratings of NexxZr T at 6-month recall Lack of sensitivity Esthetics Resistance Resistance Wear to Fracture/ to Marginal Resistance Chipping Discolor ation Retention 07

8 Quality Management System Cerifications ISO ISO 9001 CE Mark QUALITY MANAGEMENT SYSTEM - ISO 13485: 2003 This is to certify that: Sagemax Bioceramics Inc th Avenue South Suite 118 Federal Way Washington USA QUALITY MANAGEMENT SYSTEM - ISO 9001:2008 This is to certify that: Sagemax Bioceramics Inc th Avenue South Suite 118 Federal Way Washington USA Holds Certificate No: FM and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the following scope: Manufacturing and distributing of Sagemax Zr Dental zirconia blanks. Holds Certificate No: FM and operates a Quality Management System which complies with the requirements of ISO 9001:2008 for the following scope: Manufacturing and distributing of Sagemax Zr Dental zirconia blanks. For and on behalf of BSI: For and on behalf of BSI: VP Regulatory Affairs, BSI Group America Inc. Gary Fenton, Global Assurance Director Originally Registered: 12/20/2010 Effective Date: 06/28/2012 Expiry Date: 12/19/2013 Originally Registered: 12/20/2010 Latest Issue: 06/28/2012 Expiry Date: 12/19/2013 Page: 1 of 1 Page: 1 of 1 This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., Sunset Hills Road, Suite 200, Reston, VA 20190, USA. A Member of the BSI Group of Companies. This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at To be read in conjunction with the scope above or the attached appendix. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: BSI Assurance UK Limited, registered in England under number at 389 Chiswick High Road, London W4 4AL, UK. A Member of the BSI Group of Companies. 08

9 Quality System Control Maintaining a Quality System in the production of a medical device is not only mandatory but critical to the success of the product. Traceability of the materials and production control are mandated by laws and standards set by the Federal Drug Administration (FDA) under the classification of a medical device. Maintaining the quality standards requires a strong relationship between Federal guidelines, material testing, production management and document control. The Quality System reviews are carried out by regular intervals by regulatory agencies such as FDA, and independent auditors representing vendors. An external auditor qualifies our operation and internal auditors examine our system for improvements. All these system controls are designed to benefit our customers. CERAM DIVIS ION OF THE IDENTALLOY COUNC IL The manu factur er certifies that the ce ramic material provided to the laboratory with this ce rtificat e is FDAlisted Yttrium Zirconia. The laboratory ce rtifies thatth e speci fied manufactur er, mater ials, systems, and procedures were used to fabricate this prosthesis. Material / Composition Material / System Manufacturer SAGEMAX NexxZr T Zirconium Oxide (Z ro2 + HfO2) 94% Yttrium Oxide (Y 2O3) 5% SAGEMAX NexxZr T Aluminum Oxide (Al 2O3) <1% Other Oxides <1% DENTIST CERTIFICATE (attach t o patient recor d) CERAM DIVIS ION OF THE IDENTALLOY COUNC IL YTTRIUM ZIRCO NIA YZ The manu factur er certifies that the ce ramic material provided to the laboratory with this ce rtificat e is FDAlisted Yttrium Zirconia. The laboratory ce rtifies thatth e speci fied manufactur er, mater ials, systems, and procedures were used to fabricate this prosthesis. Material / Composition Material / System Manufacturer SAGEMAX NexxZr S Zirconium Oxide (Z ro2 + HfO2) 94% Yttrium Oxide (Y 2O3) 5% SAGEMAX NexxZr S Aluminum Oxide (Al 2O3) <1% Other Oxides <1% DENTIST CERTIFICATE (attach t o patient recor d) YTTRIUM ZIRCO NIA YZ CERAM DIVISION OF THE IDENTALLOY CO UNCIL YT TRIUM ZIRCON IA YZ Material / Composition SAGEMAX NexxZr T ZirconiumOxide (Z ro2 + HfO2) 94% Yttrium Oxide (Y 2O3) 5% Aluminum Oxide (Al 2O3) <1% Other Oxides <1% Material / System Manufacturer SAGEMAX NexxZr T LAB COPY CERAM DIVISION OF THE IDENTALLOY CO UNCIL YT TRIUM ZIRCON IA YZ Material / Composition SAGEMAX NexxZr S ZirconiumOxide (Z ro2 + HfO2) 94% Yttrium Oxide (Y 2O3) 5% Aluminum Oxide (Al 2O3) <1% Other Oxides <1% Material / System Manufacturer SAGEMAX NexxZr S LAB COPY

10 T : The Highest Translucency Zirconia. Sagemax manufactures an incomparable translucent zirconia. Comparative testing shows NexxZr T as having the highest translucent properties of all materials tested. By the use of special formulas, isostatic pressing and precise sinter control, results. Property Unit NexxZr TM T Value Requirement for ISO Bulk density g/cm ~ (ISO 13356:2008) Chemical composi on: ZrO2 + HfO2 + Y2O3 > 99.5 > 99 ZrO N/A Percent Mass Y2O to 6 Frac on HfO2 3 5 Al2O3 < 0.15 < 0.5 Other oxides* < 0.2 < 0.5 Microstructure: Mean linear intercept distance µm 0.25± (ISO 13356:2008) Biaxial Flexure Strength Mpa 1,150 ± CTE 10 x 10-6 (25~900 C) No ISO Fracture Toughness: Mpa M ½ 10 No ISO Radioac vity: Bq/g (ISO 13356:2008) Final Sintered Hardness: HV10 1,200~1,300 No ISO Pre-Sintered Blank Hardness: HV10 60~70 No ISO Translucency: 1-CR% (1.0mm) > 34 No ISO Highest translucency Lifelike esthetics Perfect fits Excellent machinability Absolute biocompatibility Multi-unit capability Translucency (1-CR) tested by Color i7 Proporties: 35% 1-CR translucent factor 1mm 50% total transmittance at.60mm Indications: Full contour polished Full contour stained and glazed Copings with polychromatic layering Bridges with polychromatic layering Hybrid restorations combining occlusal strength and esthetics 10

11 S : The Highest Strength Dental Zirconia. Sagemax NexxZr S is the highest strength zirconia with a biaxial flexure strength of 1500 Mpa. It has multiple uses, as lab technicians can create beautiful dental restorations by veneering porcelains over this material. NexxZr S represents the Property Unit NexxZr TM S Value Requirement for ISO Bulk density g/cm ~ (ISO 13356:2008) Chemical composi on: ZrO2 + HfO2 + Y2O3 > 99.5 > 99 ZrO N/A Percent Mass Y2O to 6 Frac on HfO2 3 5 Al2O3 < 0.3 < 0.5 Other oxides* < 0.2 < 0.5 Microstructure: Mean linear intercept distance µm 0.25± (ISO 13356:2008) Biaxial Flexure Strength Mpa 1,550 ± CTE 10 x 10-6 (25~900 C) No ISO Fracture Toughness: Mpa M ½ 10 No ISO Radioac vity: Bq/g (ISO 13356:2008) Final Sintered Hardness: HV10 1,200~1,300 No ISO Pre-Sintered Blank Hardness: HV10 65~80 No ISO Translucency: 1-CR% (1.0mm) > 30 No ISO Absolute biocompatibility Perfect fits Excellent machinability Complete versatility High strength Indications: Single crown copings with polychromatic layering Long span bridges - full arch bridges Implant substructures abutments where high strength is required Hybrid bridges - in combination with implants Strength Testing 11

12 PMMA-poly methyl methacrylate is our transparent thermoplastic material often used as an alternative to glass ceramics. It is primarily designed for production of long or short term temporary restorations. Available in various shades, this material serves well for clinical as well as laboratory needs. Benefits: Absolute biocompatibility Perfect fits Excellent machinability Strength and stability High luster polishability Stainable Available Colors: Clear White Pre-shaded º A1, A2, A3, A4, B/C Property Unit SagePMMA Value Tensile Strength MPa > 75 Biaxial Flexure Strength MPa > 120 Elongation % 3 Refractive Index Water Absorption µg/mm 3 0.3~0.4% Composition Polymethyl Methacrylate 12

13 designs. Sagemax wax discs are a blend of wax and acrylic, merging the best qualities of each. The ease of machinability of wax combined with the higher melting point of acrylic allows the user to cast directly. Burns out clean Leaves no residue Ash free Easy machinability Low coefficient of thermal expansion Excellent fit after cost Property Unit SageWAX Value Hardness Mpa > 53 Flexibility High > 45 Drop mel ng point C 105~135 Flash point C 300 Water Absorp on µg/mm 3 Insoluble Composi on Poly Wax Available Colors: Blue Wax Indications Cast copings Full contour cast Burnout and press over zirconia All burnout and cast needs Pressing and Over Pressing White Wax Esthetically pleasing for diagnostic presentations, these waxes are designed to alleviate the high production cost associated with manual hand waxing techniques. Indications Diagnostic presentations Burn out and cast 13

14 Sagemax has developed a unique prestain paste for use with NexxZr T and NexxZr S. It is possible to achieve good color matches with maximum saturation in ten to twenty seconds. All 16 Vita shades are available and since these color pastes are alcohol based, it is a predictable and safe method. Fully sintered NexxZr T and NexxZr S can be shaded externally with any reputable stain and glaze. Users of Sagemax color pastes will experience substantial savings in time and cost

15 NexxZr Capability Sagemax NexxZr T and NexxZr S offer great esthetics, strength, and versatility. Its translucent levels are the highest of all zirconia tested. Several types of restorations can be fabricated with Sagemax zirconia, all with exceptional results. The user now has a choice to create restorations to whatever level of esthetics they desire. It is possible to fabricate at least 5 different types of restorations using NexxZr. TP C E R T I F I E D C R O W N B R I D G E TG C E R T I F I E D C R O W N B R I D G E ETH C E R T I F I E D C R O W N B R I D G TL C E R T I F I E D C R O W N B R I D G E SL C E R T I F I E D C R O W N B R I D G E 1. Prestained, sintered and polished (TP) 2. Prestained, sintered, and externally stained (TG) 3. Hybrid type, with minimum cutback and layering for esthetics (TH) 4. Prestained coping for polychromatic layering using NexxZr T (TL) 5. Prestained coping for polychromatic layering using NexxZr S (SL) Clinical tests have revealed excellent results in patients with Sagemax restorations. Clinicians as well as patients experience a great deal of satisfaction with the various choices of restorations that can be created with relative ease. Complete instructions and training are available from Sagemax. All the above mentioned types of restorations can yield exceptional results. The various types are dependent on the specific requirements evaluated by the clinicians and the dental laboratories. 15

16 Shapes and Sizes W-98 Disc A-71 Disc R-99 Disc S-Blank Z-95 Disc D-98 Disc Customized shapes and sizes are also available. 16

17 W-98 Disc Product List Compatibility: Dimension: Thickness: Materials / Shades: Wieland ZENO and most open architecture dental milling systems 98.4 mm disc with step 10 mm, 12 mm, 14 mm, 16 mm 18 mm, 20 mm, 22 mm, 25 mm T No Shade Pre-Shade: A1, A3, B1, B3, C1, C3, D2 S No Shade Pre-Shade: S1, S2, S3, S4, S5 Clear White Pre-Shade: A1, A2, A3, A4, B/C Blue White Wieland ZENO is not a registered trademark of Sagemax. 17

18 R-99 Disc Product List Compatibility: Roland DWX 30/50 CAD/CAM System Dimension: Thickness: Materials / Shades: 99mm diameter with step 10 mm, 12 mm, 14 mm, 16 mm 18 mm, 20 mm, 22 mm, 25 mm T No Shade Pre-Shade: A1, A3, B1, B3, C1, C3, D2 S No Shade Pre-Shade: S1, S2, S3, S4, S5 Clear White Pre-Shade: A1, A2, A3, A4, B/C Blue White Roland is not a registered trademark of Sagemax. 25

19 Z-95 Zr Disc (No Shade) T -Highest Translucency WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr T / Z NT-WT Z9510NTWT1 Ø95 x H10 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9512NTWT1 Ø95 x H12 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9514NTWT1 Ø95 x H14 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9516NTWT1 Ø95 x H16 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9518NTWT1 Ø95 x H18 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9522NTWT1 Ø95 x H22 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9525NTWT1 Ø95 x H25 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / Z NT-WT Z9530NTWT1 Ø95 x H30 (mm) NT Zirconia White 1 Disc/Pack S -Highest Strength WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr S / Z NS-WT Z9510NSWT1 Ø95 x H10 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9512NSWT1 Ø95 x H12 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9514NSWT1 Ø95 x H14 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9516NSWT1 Ø95 x H16 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9518NSWT1 Ø95 x H18 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9522NSWT1 Ø95 x H22 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9525NSWT1 Ø95 x H25 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / Z NS-WT Z9530NSWT1 Ø95 x H30 (mm) NS Zirconia White 1 Disc/Pack 34

20 A-71 Zr Disc (No Shade) T -Highest Translucency WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr T / A NT-WT A7112NTWT1 Ø71 x H12 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / A NT-WT A7114NTWT1 Ø71 x H14 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / A NT-WT A7116NTWT1 Ø71 x H16 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / A NT-WT A7118NTWT1 Ø71 x H18 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / A NT-WT A7120NTWT1 Ø71 x H20 (mm) NT Zirconia White 1 Disc/Pack S -Highest Strength WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr T / A NS-WT A7112NSWT1 Ø71 x H12 (mm) NS Zirconia White 1 Disc/Pack NexxZr T / A NS-WT A7114NSWT1 Ø71 x H14 (mm) NS Zirconia White 1 Disc/Pack NexxZr T / A NS-WT A7116NSWT1 Ø71 x H16 (mm) NS Zirconia White 1 Disc/Pack NexxZr T / A NS-WT A7118NSWT1 Ø71 x H18 (mm) NS Zirconia White 1 Disc/Pack NexxZr T / A NS-WT A7120NSWT1 Ø71 x H20 (mm) NS Zirconia White 1 Disc/Pack 42

21 D-98 Zr Disc (No Shade) T -Highest Translucency WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr T / D NT-WT D9810NTWT1 Ø98.4 x H10 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9812NTWT1 Ø98.4 x H12 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9814NTWT1 Ø98.4 x H14 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9816NTWT1 Ø98.4 x H16 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9818NTWT1 Ø98.4 x H18 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9820NTWT1 Ø98.4 x H20 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9822NTWT1 Ø98.4 x H22 (mm) NT Zirconia White 1 Disc/Pack NexxZr T / D NT-WT D9825NTWT1 Ø98.4 x H25 (mm) NT Zirconia White 1 Disc/Pack S -Highest Strength WT PRODUCT / MODEL REF # DIMENSION MATERIAL SHADE PACKAGE NexxZr S / D NS-WT D9810NSWT1 Ø98.4 x H10 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9812NSWT1 Ø98.4 x H12 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9814NSWT1 Ø98.4 x H14 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9816NSWT1 Ø98.4 x H16 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9818NSWT1 Ø98.4 x H18 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9820NSWT1 Ø98.4 x H20 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9822NSWT1 Ø98.4 x H22 (mm) NS Zirconia White 1 Disc/Pack NexxZr S / D NS-WT D9825NSWT1 Ø98.4 x H25 (mm) NS Zirconia White 1 Disc/Pack 50

22 Contacts USA Headquarters Sagemax Bioceramics, Inc th Ave. S. Suite 118 Federal Way, WA 98003, USA Toll Free: Phone: Germany Sagemax Dental GmbH Rigaer Str Berlin, Germany Toll Free: Phone: Netherlands Sagemax Distribution Center Valkweg EC Schiphol The Netherlands sdc-eu@sagemax.com Italy Sagemax Europe SRL Via Principe Amedeo Milano, Italy Phone: ++39 (0) eu@sagemax.com Russia Sagemax Russia 34/1 Novy Arbat Street, Suite Moscow, Russian Federation Phone: russia@sagemax.com Hong Kong Sagemax Distribution Center 1-11 Ka Ting Road, Kwai Chung, N.T., Hong Kong sdc-hk@sagemax.com 61