MSCB-001

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2016 GC America Inc. Dr. Mark Heiss Director, Regulatory & Academic Affairs 3737 W. 127th Street Alsip, Illinois 60803 Re: K152274 Trade/Device Name: MSCB-001 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: February 22, 2016 Received: February 24, 2016 # Dear Dr. Heiss: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang - for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Section 4 - Indications for Use Statement Indications for Use 510(k) Number (if known): K152274 Device Name: MSCB-001 Indications for Use: 1. Metal free indirect restorations: full crown, inlays, onlays, laminated veneer Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 4.1 of 4.1 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the letters 'GC' in a stylized font. The letters are in a dark teal color and are set against a white background. There are two apostrophe-like marks, one on either side of the letters. The letters are bold and slightly slanted, giving them a dynamic appearance. GC AMERICA INC. 3737 WEST 127TH STREET ALSIP, ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103 - 1. Submitter: | GC AMERICA INC. | | |----------------------|--------------------| | 3737 W. 127th Street | | | Alsip, IL 60803 | | | Contact Person: | Mark Heiss, D.D.S. | | Phone: | (708) 926-3090 | | Alternate Contact: | Lori Rietman | | Phone: | (708)-926-3092 | | Fax: | (708) 926-9100 | | Date Prepared: | August 7, 2015 | - 2. Device Name: | Proprietary Name: | MSCB-001 | |------------------------|-----------------------------------| | Classification Name: | Porcelain Powder for Clinical Use | | Device Classification: | Class II, 872.6660 | | Product Code: | EIH | - 3. Predicate Devices: | Company | Device | 510(k) No. | Date Cleared | |------------------|-----------------------------|------------|--------------| | Vita Zahnfarbrik | VITABLOCS FOR CEREC MARK II | K022408 | 7/24/2002 | - Description of Device: 4. MSCB is a block system consisting of a porcelain block cemented to a milling machine specific mandrel. This block/mandrel is designed to be milled in a CAD/CAM milling machine that is programmed to fabricate an indirect restoration. After milling, the restoration can be customized by use of porcelain stain. The composition of this product allows for milling without need to fire in a porcelain furnace. MSCB-001 system is a feldspathic (glass) porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or sodafeldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement. - 5. Indications for Use: 1. Metal free indirect restorations: full crown, inlays, onlays, and laminated veneer ### Package 6. - 1. 3 sizes: 12/ 14/ 14L - 2. 5 blocks in one package - 3. Available CAD/CAM system: Aadva/ CEREC /E4D - 7. Shades 5 Vita* shades available in two translucencies: - High Translucency (HT): A1 HT, A2 HT, A3 HT, A3.5 HT, B1 HT - Low Translucency (LT): A1 LT, A2 LT, A3 LT, A3.5 LT, B1 LT {4}------------------------------------------------ - One bleach shade (BL) - Low Translucency (LT): A1 LT, A2 LT, A3 LT, A3.5 LT, B1 LT - One bleach shade (BL) * Vita® is a registered trademark of Vita Zahnfabrik, Bad Säckingen, Germany, ### 8. Shelf Life: 10 years from date of manufacture ### 9. Biocompatibility According to ISO 10993-1: 2009, the following is stated: *Sec 4.1 "Evaluation may include both a study of relevant preclinical experience and actual testing. Such an evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe history of use in a specified role and physical form that is equivalent to that of the device under design." *Sec 6.1 "Material characterization: "If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, then further characterization and biological evaluation might not be necessary." All components in MSCB-001 have been used in predicate product, such as VITABLOCS FOR CEREC. Based on above, MSCB was considered to have an acceptable level of biocompatibility All devices come in contact with the same body tissues (tooth - enamel, dentin) for more than 24 hours. #### 10. Performance Testing - Bench: It is confirmed that the device conforms to the required specifications of ISO 6872:2008 and is suitable for its intended use. Performance testing includes: - . Chemical solubility - . Flexural strength - Linear thermal expansion . - o Radioactivity #### Technological characteristics: 11. All the components of the applicant device, MSCB-001, have already been used in the predicate device (VITABLOCS FOR CEREC MARK II). - 12. Substantial equivalence: The new and predicate device (VITABLOCS FOR CEREC MARK II) are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices. The substantial equivalence was viewed looking at comparison to standards as well as the predicate device. # Differences: Compared to VITABLOCS FOR CEREC MARK II, MSCB-001 has a higher flexural strength using ISO 6872. - 13. Conclusion Based on a comparison of intended use, indication for use, composition, and shelf life, GC concludes that MSCB-001 is substantially equivalent to the predicate device (VITABLOCS FOR CEREC MARK II: K022408). {5}------------------------------------------------ # Table 5.1.1 Comparison Table | | Applicant device | Comparative device | Difference<br>Y/N | Rationale | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product<br>category | CAD/CAM restorative | CAD/CAM restorative | | | | Trade name | MSCB-001 | VITABLOCS FOR CEREC<br>MARK II (K022408) | | | | Manufacturer<br>Indications | Klema Dentalprodukte<br>1. Metal free indirect<br>restorations: full crown, inlays,<br>onlays, laminated veneer | Vita Zahnfarbrik<br>Fabrication of inlays, onlays,<br>partial and full crowns,<br>endo-crowns of molars, and<br>veneers | Y | We have added the<br>word "metal free" to<br>clarify the classification<br>of material type the<br>applicant device is part<br>of. Since the applicant &<br>predicate device are<br>both metal free<br>ceramics, the technical<br>description & function | | Product<br>description | MSCB is a block system<br>consisting of a porcelain block<br>cemented to a milling machine<br>specific mandrel. This<br>block/mandrel is designed to<br>be milled in a CAD/CAM<br>milling machine that is<br>programmed to fabricate an<br>indirect restoration. After<br>milling, the restoration can be<br>customized by use of<br>porcelain stain. The com-<br>position of this product allows<br>for milling without need to fire<br>in a porcelain furnace. | VITABLOCS are industrially<br>manufactured, fine-structure<br>feldspar ceramic blocks used to<br>fabricate inlays, onlays,<br>veneers and crowns with<br>CEREC and inLab CAD/CAM<br>systems of Sirona Dental<br>Systems GmbH. | Y | have not changed.<br>Though the verbiage is<br>different, the type of<br>material, Feldspar type<br>ceramic is the same as<br>well as its form (Block<br>on mandrel). Both<br>products fabricate<br>indirect restoration<br>using the same<br>technology. The<br>different term that the<br>applicant device used is<br>"CAD/CAM milling<br>machine." | | Instructions<br>for use | 1. Preparation design<br>2. Milling<br>3. Finishing and polishing<br>4. Cementation with<br>sandblasting technique<br>5. Cementation without<br>sandblasting technique<br>6. Characterization | Fabrication of the restoration in<br>the dental laboratory:<br>1. CAD design with inLab 3D<br>software.<br>2. Milling of the restoration<br>with inLab.<br>3. Placing the restoration on<br>the model.<br>4. Finishing & polishing on<br>the model. Alternatively:<br>characterization/individuali<br>zation of the shade<br>Fabrication of the restoration in<br>the dental practice:<br>1. Finishing & polishing.<br>2. Alternatively:<br>Characterization of the<br>shade,<br>individualizing/glazing.<br>3. Adhesive bonding:<br>• Ceramic etching<br>• Silanization | Y | No impact.<br>Different verbiage for<br>similar processes. | {6}------------------------------------------------ | | Enamel/dentine etching Adhesive system Adhesive composite Oxygen protection gel 4. Finishing & final polishing | |--|-----------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------| Differences in verbiage of indications, product description and instructions for use are noted above. Review of these categories between predicate and applicant device demonstrated that these products had similar indications (same clinical utilization), similar description and instructions. The variations noted and described demonstrate that the predicate and applicant device have similar clinical use that can be manage by the dental professional. | Property /Unit | Standards | Requirements | Test results | | | |--------------------------------|-------------------|---------------------------------------|---------------|---------------|------------------------| | | | | MSCB<br>LT A2 | MSCB<br>HT A2 | CEREC VITABLOCS<br>MK2 | | Chemical<br>solubility | ISO 6872:<br>2008 | Less than 100 µg/cm³ | 34 µg/cm³ | 33 µg/cm³ | 29 µg/cm³ | | | | | 31 µg/cm³ | 35 µg/cm³ | 30 µg/cm³ | | | | | 29 µg/cm³ | 39 µg/cm³ | 35 µg/cm³ | | | | Average | 31 | 35 | 31 | | | | St. Dev. | 2.5 | 3.0 | 3.2 | | Flexural<br>strength | ISO 6872:<br>2008 | Greater than 100 MPa | 210 MPa | 207 MPa | 154 MPa | | | | | 215 MPa | 220 MPa | 140 MPa | | | | | 205 MPa | 215 MPa | 142 MPa | | | | Average | 210 | 214 | 145 | | | | St. Dev. | 5 | 6.5 | 7.5 | | Linear<br>thermal<br>expansion | ISO 6872:<br>2008 | TG(°C)<br>+/- 10 | 470°C | 465°C | 780°C | | | | | 468°C | 468°C | 790°C | | | | | 472°C | 475C | 785°C | | | | Average | 470°C | 469°C | 785° | | | | St. Dev. | 2 | 5 | 5 | | Radioactivity | ISO 6872:<br>2008 | Radioactivity A ≤ 1.0 By/g<br>an 238U | Conformed | Conformed | Conformed | # Table 5.2.1 Summary of Performance Specifications Comparing test results between applicant and predicate device for the properties of chemical solubility they were statistically equivalent and met or exceeded requirements of ISO 6872:2008. Comparing test results between application and predicate device for the properties of flexural strength, they were statistically different with MSCB-001 having higher values. Both devices exceeded performance specification minimum. Comparing test results between predicate and applicant device for linear thermal expansion with a TG of +/-10℃, the standard deviation of products tested were within the SD limitations requirement. The properties listed, tested and results indicate that the application and predicate device are within the standard ISO 6872:2008. When compared to the predicate device already in the market, the performances of MSCB-001 are at least statistically equivalent and, therefore, can be considered clinically acceptable.