Inclusive Titanium Abutments compatible with: Hiossen HG Implant System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 7, 2015 PRISMATIK DENTALCRAFT, INC. Mr. Armin Zehtabchi Senior RA 2212 Dupont Dr., Suite P Irvine, California 92612 Re: K151375 > Trade/Device Name: Inclusive Titanium Abutments compatible with: Hiossen HG Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 21, 2015 Received: May 22, 2015 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. {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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S 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}------------------------------------------------ | Form Approved: OMB No. 0910-0120 | | |-----------------------------------|--| | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | | 510(k) Number (if known) | TBD | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System | | Indications for Use (Describe) | Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." B. ## 006_510 (K) Summary-807.92(c) This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92. ### SUBMITTER INFORMATION A. | 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: | September 25, 2015 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | Inclusive® Titanium Abutments compatible<br>with: Hiossen HG Implant System | | 21 CFR Reference: | 21 CFR 872.3630 | | 21 CFR Common Name: | Abutment, implant, dental, endosseous | | Classification: | Class II, NHA | | Panel: | Dental | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient from blue to pink. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in a sans-serif font. The text is a dark teal color. #### C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Predicate Device: Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants=510(k)-K100993 Reference Device: HS/HG Prosthetic System-510(k)k100245 ### D. PROPOSED DEVICE DESCRIPTION Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard). The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm. #### E. INDICATIONS FOR USE Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid to prosthetic rehabilitation. #### DETERMINATION OF SUBSTANTIAL EQUIVALENCE F. Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System is substantially equivalent to the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. They are substantially equivalent in intended use, materials, design and performance. (See Comparison Tables below) {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 a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. | Attribute | Reference Device (1) | Predicate Device (1) | Proposed Device | Similarities<br>and<br>Differences<br>of Devices | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | | HS/HG Prosthetic<br>System (K100245)<br>Osstem Implant<br>Co. Ltd<br>(Subsidiary of<br>Hiossen Inc) | Inclusive® Titanium Abutment<br>for Astra Tech OsseoSpeed™<br>Implants (K100993)<br>Prismatik Dentalcraft, Inc. | Inclusive Titanium<br>Abutments compatible<br>with: Hiossen HG Implant<br>System<br>Prismatik Dentalcraft, Inc. | | | Dimensions of<br>Abutment | Mini - 2.1 Across<br>Flats of Hex<br>Standard - 2.5<br>Across Flats of<br>Hex | 3.5/4.0 - 2.1 Across Flats of Hex<br>4.5/5.0 - 2.5 Across Flats of Hex | Mini - 2.1 Across Flats of<br>Hex<br>Standard - 2.5 Across Flats of<br>Hex | Same | | Dimensions of<br>Abutment Screw | Mini - Length -<br>10.7mm, Screw<br>Head - 2.2mm<br>Standard - Length -<br>8.85mm, Screw<br>Head - 2.5mm | 3.5/4.0 - Length 8.25mm, Screw<br>Head 2.33mm 4.5/5.0 - Length -<br>10.3mm, Screw Head 2.33mm | Mini - Length - 10.3mm,<br>Screw Head - 2.2mm<br>Standard - Length - 8.35mm,<br>Screw Head - 2.3mm | Different<br>screws<br>dimensions | | Indications for<br>Use | HS/HG Prosthetic<br>System is intended<br>for use with the<br>dental implant to<br>provide support for<br>prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | The Inclusive Titanium<br>Abutments for Astra<br>OsseoSpeed™ Implants are<br>premanufactured<br>prosthetic components directly<br>connected to endlosseous dental<br>implants and are intended<br>for use as an aid in prosthetic<br>rehabilitation. They are<br>compatible with the Astra Tech<br>OsseoSpeed™ 3.0, 3.5, 4.0, 4.5,<br>5.0 implants. | Inclusive Titanium<br>Abutments are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implant and are<br>intended for use as an aid in<br>prosthetic rehabilitation. | Similar<br>intended use<br>for the<br>additional use<br>with Hiossen<br>mini<br>2.1 and<br>Standard 2.5 | | Platform<br>Diameter<br>Compatibility | Hiossen HG Mini<br>(2.1 Across Flats<br>of Hex and<br>Standard (2.5<br>Across Flats of<br>Hex | Astra Tech OsseoSpeed™<br>Implants 3.5/4.0<br>4.5/5.0 | Hiossen HG<br>Mini - 2.1 Across Flats of<br>Hex<br>Standard - 2.5 Across Flats<br>of Hex | Same as<br>Reference<br>predicate | | Connection | Hexagonal | Hexagonal | Hexagonal | Same | | Material | Titanium alloy<br>(Ti-6AL-4V) | Titanium alloy<br>(Ti-6AL-4V) | Titanium alloy<br>(Ti-6AL-4V) | Same | | Design /<br>Construction | Machined | Machined | Machined | Same | | Attribute | Reference Device (1) | Predicate Device (1) | Proposed Device | Similarities<br>and<br>Differences<br>of Devices | | | HS/HG Prosthetic<br>System<br>(K100245)<br>Osstem Implant<br>Co. Ltd<br>(Subsidiary of<br>Hiossen Inc) | Inclusive® Titanium Abutment<br>for Astra Tech OsseoSpeed™<br>Implants (K100993)<br>Prismatik Dentalcraft, Inc. | Inclusive Titanium<br>Abutments compatible<br>with: Hiossen HG Implant<br>System<br>Prismatik Dentalcraft, Inc. | | | Anatomical Site /<br>Placement | Oral Cavity /<br>Tissue Level | Oral Cavity / Tissue Level | Oral Cavity / Tissue Level | Same | | Abutment Angle | 0-30° | 0-20° | 0-30° | Similar | # Table 1 – Comparison between Predicate and Proposed Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors radiating from the center. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text. #### G. NON-CLINICAL TESTING (PERFORMANCE DATA) Non-clinical test data was used to evaluate the device's equivalence, and determine substantial equivalence with predicate devices. Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems, and the testing results and evaluations demonstrate the implant to abutment compatibility between the proposed and predicate/reference devices. The detailed discussion and the testing procedure can be found in Section 018 (Performance Testing-Bench). The applicable standards that are used in this submission are listed below: | | Applicable Standards | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASTM F136-12a | Standard for Wrought Titanium-6Aluminum-<br>4Vanadium ELI (Extra Low Interstitial) Alloy<br>for Surgical Implant Applications | | AAMI/ANSI/ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part<br>1: Evaluation and Testing within a Risk<br>Management Process (Biocompatibility) | | ISO14801:2007 | Dentistry - Implants - Dynamic fatigue test for<br>endosseous dental implants | | AAMI/ANSI 17665:-1:2006 | Sterilization of health care products - Moist Heat<br>- Part 1: Requirements for the development,<br>validation and routine control of a sterilization<br>process for medical devices | | AAMI/ANSI/ISO 17665-2:2009 | Sterilization of Health Care Products - Radiation<br>- Part 2: Guidance of on the application of ISO<br>17665-1 | | ANSI/AAMI ST79:2010 &A1:2010 &<br>A2:2011 & A3:2012 & A4:2013 | (Consolidated Text) Comprehensive guide to<br>steam sterilization and sterility assurance in<br>health care facilities | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including blue, pink, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. Inclusive® Titanium Abutments are manufactured from biocompatible titanium grade 23 (Ti-6AL-4V ELI) and it meets ASTM F-136 Standard. In accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", in lieu of performing biocompatibility testing per ISO 10993-1 for the subject device, we have identified several of Prismatik own predicate devices with identical materials, same manufacturing process, and same type/duration of patient contact: - K073217, Inclusive® Abutment for Zimmer, 3i and Nobel Biocare Implants - - K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed Implants - - K121391, Inclusive® Titanium Abutment for Camlog Screw-Line Implants - In addition, sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use. #### CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA) H. The proposed device, the Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System have the same performance specifications, fundamental scientific technology and intended use as that of the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. The testing performed demonstrated implant to abutment compatibility and supports the substantial equivalence of the subject device to the identified predicate.