OBSIDIAN PRESS (ALL CERAMIC AND POM)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be moving forward. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 6,2014 Prismatik DentalCraft, Inc. Armin Zehtabchi Senior RA Specialist 2212 Dupont Drive. Suite P Irvine California 92612 Re: K141887 Trade/Device Name: Obsidian TM Press (All Ceramic and POM) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: August 26, 2014 Received: September 29, 2014 Dear Mr. Zehtabchi: 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. 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 {1}------------------------------------------------ Page 2 - Mr. Zehtabchi 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. Susan Runno DDS, mA 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 {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K141887 Device Name ObsidianTM Press (All-Ceramic and POM) ## Indications for Use (Describe) The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods. ### Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ B. ## 006-510 (K) Summary-807.92(c) This 510 (k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. #### A. SUBMITTER INFORMATION | Company Name: | Prismatik Dentalcraft, Inc. | |-------------------------------|------------------------------------------------------------| | Company Address: | 2212 Dupont Dr., Suite P,<br>Irvine, CA 92612 | | Company Phone: | 949-225-1269 | | Company FAX: | 949-553-0924 | | Facility Registration Number: | 3005477956 | | Primary Contact Person: | Armin Zehtabchi, (949) 225-1234<br>Senior RA Specialist | | Secondary Contact Person | Marilyn Pourazar, (949) 225-1269<br>Senior Director, RA/QA | | Date Summary Prepared: | November 5, 2014 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | Obsidian™ Press (All-Ceramic and POM) | | 21 CFR Reference: | 21 CFR 872.6660 | | 21 CFR Common Name: | Porcelain powder for clinical use | | Classification: | Class II, EIH | | Panel: | Dental | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangular prism with a color gradient on the left side. The text "PRISMATIK DENTALCRAFT, INC." is located to the right of the prism. #### C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: - Obsidian™ Ceramic Blocks-K100781 ● - IPS e.max Press and IPS e.max Press Multi (Ivoclar Vivadent, Incorporated)-K120134 - IPS 99 One and IPS 99 Ceram ● (Ivoclar Vivadent, Incorporated)-510(k)-K121359 #### D. DEVICE DESCRIPTION Obsidian™ Press is a lithium silicate ceramic to be supplied in the form of ingots to be pressed to temperature in various furnaces. The increased Obsidian™ Press CTE value is intended to allow the Obsidian™ Press ceramic to be used in Press Over Metal applications, using various approved dental alloys, in addition to the all ceramic applications. The ingots are designed to be pressed into a variety of restorations including Press Over Metal (POM) such as full contour crowns and bridges, as well as monolithic all-ceramic restorations such as full contour crowns, up to 3-unit anterior bridges (including pre-molar region as terminal abutment), inlays, onlays, partial crowns, and veneers with esthetics, translucency, and strength. The ingots will be available in the commonly used VITA Classical and Chromascop Bleach shades. #### E. INDICATIONS FOR USE The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, partial crowns, veneers, inlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods. #### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE The comparison table below outlines and provides the similarities and the substantial equivalency of the predicate devices, Obsidian™ Ceramic Blocks, 510(k)-K100781, IPS e.max Press and IPS e.max Press Multi (Ivoclar Vivadent, Incorporated), 510(k)-K120134, IPS 99 One and IPS 99 Ceram (Ivoclar Vivadent, Incorporated), 510(k)-K121359 and the proposed device, Obsidian™ Press (All-Ceramic and POM), and Prismatik believes that the comparative data presented in the preceding paragraphs, demonstrate that Obsidian™ Press (All-Ceramic and POM) is essentially the same as currently marketed devices for the same indication for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of Porcelain powder for clinical use (21 CFR 872.6660) that have previously been found to be substantially equivalent, and that any differences between the proposed device, Obsidian™ Press (All-Ceramic and POM) and the predicate device do not introduce any new issues of safety or effectiveness. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. | Attributes | Predicate Devices | | IPS 99 One and IPS<br>99 Ceram<br>(Vivadent,<br>Incorporated)<br>510(k)-K121359 | Proposed Device | Similarities<br>and<br>Differences<br>Between the<br>Predicate<br>and the<br>Proposed<br>Device | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Indications for<br>Use | This device is used<br>to fabricate<br>ceramic dental<br>prostheses in the<br>nature of crowns<br>and bridges for<br>posterior and<br>anterior<br>applications using<br>CAD/CAM or hot-<br>press methods. | IPS e.max Press<br>and IPS e.max<br>Press Multi (Ivoclar<br>Vivadent,<br>Incorporated)<br>510(k)K120134 | IPS 99 One is a<br>one-layer<br>veneering ceramic<br>for the fabrication<br>of metal-ceramic<br>restorations using<br>the most popular<br>dental alloys in the<br>CTE range of 13.8-<br>15.0 x 10-6/K (25-<br>500°C)<br>IPS 99 Ceram is a<br>conventional multi-<br>layer veneering<br>ceramic for the<br>fabrication of metal<br>ceramic<br>restorations using<br>the most popular<br>dental alloys in the<br>range of 13.8-15.0<br>x 10-6/K (25-<br>500°C).<br>IPS 99 is intended<br>to be used for<br>inlays, onlays,<br>veneers, and<br>anterior/posterior<br>PFM crowns. | The Obsidian™<br>Press ceramic is<br>used to fabricate<br>Press Over Metal<br>dental prostheses in<br>the nature of crowns<br>and bridges as well<br>as monolithic dental<br>prostheses in the<br>nature of crowns,<br>partial crowns,<br>veneers, inlays, and<br>onlays for posterior<br>and anterior<br>applications, as<br>well as 3-unit<br>anterior bridges<br>(including pre-molar<br>region as terminal<br>abutment) using<br>pressing methods. | Substantially<br>equivalent | | Shades | A1, A2, A3, A35,<br>B1, B2, B3, C1,<br>C2, C3, D2, D3,<br>BL1 and BL4 | High and low<br>translucencies): 16<br>A-D and 4 Bleach<br>BL shades | A1, A2, A3, A35,<br>B1, B2, B3, C1,<br>C2, D2, D3, BL1<br>and BL4 | A1, A2, A3, A35,<br>B1, B2, B3, C1, C2,<br>D2, D3, BL1 and<br>BL4 | Same | | Flexural Strength | >300 MPa<br>(meeting ISO 6872<br>requirements) | >300 MPa<br>(meeting ISO 6872<br>requirements) | >300 MPa<br>(meeting ISO 6872<br>requirements) | >300 MPa<br>(meeting ISO 6872<br>requirements) | Same | | Chemical<br>Solubility | < 100µg/cm²<br>(meeting ISO 6872<br>requirements) | < 100µg/cm²<br>(meeting ISO 6872<br>requirements) | < 100µg/cm²<br>(meeting ISO 6872<br>requirements) | < 100µg/cm²<br>(meeting ISO 6872<br>requirements) | Same | | | Predicate Devices | | | Proposed Device | Similarities<br>and | | Attributes | Obsidian™ Ceramic<br>Blocks<br>510(k)-K100781 | IPS e.max Press and<br>IPS e.max Press<br>Multi (Ivoclar<br>Vivadent.<br>Incorporated)<br>510(k)-K120134 | IPS 99 One and IPS<br>99 Ceram<br>(Vivadent,<br>Incorporated)<br>510(k)-K121359 | Obsidian™ Press (All<br>Ceramic and POM) | Differences<br>Between the<br>Predicate<br>and the<br>Proposed<br>Device | | Freedom from<br>Extraneous<br>Material | Shall be free from<br>extraneous<br>materials when<br>assessed by visual<br>inspection (meeting<br>ISO 6872<br>requirements) | Shall be free from<br>extraneous<br>materials when<br>assessed by visual<br>inspection (meeting<br>ISO 6872<br>requirements) | Shall be free from<br>extraneous<br>materials when<br>assessed by visual<br>inspection (meeting<br>ISO 6872<br>requirements) | Shall be free from<br>extraneous materials<br>when assessed by<br>visual inspection<br>(meeting ISO 6872<br>requirements ) | Same | | Radioactivity | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Activity<br>concentration of<br>uranium238 less than<br>1.0Bq g-1 (meeting<br>ISO 6872<br>requirements) | Same | | Coefficient of<br>Thermal<br>Expansion<br>(25-500°C) | 12.2+/-0.5 x10-6 °C<br>(meeting ISO 6872<br>requirements) | 12.2+/-0.5 x10-6 °C<br>(meeting ISO 6872<br>requirements) | 12.2+/-0.5 x10-6 °C<br>(meeting ISO 6872<br>requirements) | 12.2+/-0.5 x 10-6 °C<br>(meeting ISO 6872<br>requirements) | Same | | Biocompatibility | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and 10993-<br>10 Requirements) | Same | # Table 1 – Comparison between Predicate and Proposed Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is made up of different colors, including pink, blue, and green. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. #### SUMMARY OF NON-CLINICAL TESTING/PERFORMANCE DATA G. To meet the ISO 6872 requirements, various non-clinical and applicable tests were performed, and the tests results for the Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, and Coefficient Thermal Expansion indicate the Obsidian™ Press (All Ceramic and POM) is comparable to the predicate devices. In addition, the Obsidian™ Press (All-Ceramic and POM) has been tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) to meet the biocompatibility requirement and the reports are as follow: - The Cytotoxicity Report shows that there was no reaction on any of the cells. - The Sensitization Report shows that there was no reaction on the tested subject. ● - The Irritation Report shows that there was no erythema or edema on the test subject. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular shape with a rainbow gradient, with colors ranging from blue to pink. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is colored in a dark blue. | Test Description | Results | |------------------------------------------------------------------------------------------------------|---------| | Cytotoxicity Study using the IX MEM extraction method at 37°C | Pass | | ISO Intracutaneous Study, Extract 0.9% sodium chloride USP solution (SC)<br>and sesame oil, NF (SO) | Pass | | Irritation and Skin Sensitization Study, Extract 0.9% sodium chloride USP<br>and sesame oil, NF (SO) | Pass | A copy of the tests result is provided in the Attachment A. #### H. CONCLUSION FROM THE NON-CLINICAL TESTING/ PERFORMANCE DATA The proposed Obsidian™ Press (All-Ceramic and POM) has the same performance specifications, fundamental scientific technology and intended use as that of the predicate devices, Obsidian" Ceramic Blocks 510(k)-K100781, IPS e.max Press and IPS e.max Press Multi (Ivoclar Vivadent, Incorporated), 510(k)-K120134 and IPS 99 One and IPS 99 Ceram (Ivoclar Vivadent, Incorporated), 510(k)-K121359. These devices are substantially equivalent, and that any differences between the Obsidian™ Press (All-Ceramic and POM) and the cited predicate devices do not introduce any new issues of safety or effectiveness.