ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS

{0}------------------------------------------------ Berkeley zimplant = Precision Implant Technology 342 Raritan Center Parkway, Edison, New Jersey 08837 K101068 Phone: 732-346-1000 Fax: 732-875-1169 #### 510(K) Summary VI. - | | Company Name: | Radiant Express LLC<br>DBA: Berkeley Implant | |--|-----------------------------|------------------------------------------------| | | Address: | 342 Raritan Center Parkway<br>Edison, NJ 08837 | | | Telephone Number: | (732) 346-1000 | | | Fax Number: | (732) 875-1169 | | | Estab. Registration Number: | K101068 | | | Owner/Operator Number: | 9087046 | | | Submitter's Name: | Ryan Chiou | | | Contact Person: | Ryan Chiou | | | Date Summary Prepared: | April 10, 2010 | | | Classification Name: | Abutment, Implant, Dental, Endosseous | | | Common/Usual Name: | Endosseous dental implant abutment | | | Device Trade Name: | AccuFitTM Dental Implant Abutments & Screws | | | Predicate Devices: | See tables B & C below | ### 1. Description: The AccuFit" Dental Abutments and Screws are designed for use with commercially available dental implant systems. The abutments will seat directly on implants and are secured by screws to become sub-structure of prosthesis. These abutments are offered in a straight body with a straight or scalloped prosthetic margin and are made of Titanium alloy Ti6AlV4. A list of dental implant systems, which the AccuFit™ family of products is compatible with, is shown in tables within this document. The abutments and screws of the compatible systems are listed as the predicates for this filing. The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes: Table A. Compatible Commercial Implant Manufacturers | Implant Company | Implant System | Implant Platform Diameter | |-----------------|------------------------|---------------------------| | Zimmer Dental | Tapered Screw-vent | 3.5, 4.5, 5.7 mm | | Nobel-Biocare | NobelReplace Select | 3.5, 4.3, 5.0 mm | | Biomet 3i | Osseotite Certain | 3.4, 4.1, 5.0 mm | | Lifecore | Renova (internal hex) | 3.5, 4.5 mm | | Biomedical | Restore (external hex) | 3.3, 4.1, 5.0 mm | {1}------------------------------------------------ 342 Raritan Center Parkway, Edison, New Jersey 08837 # 2. Intended Use: AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla. AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant. The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes: | Implant Company | Implant System | Implant Platform Diameter | |-----------------|------------------------|---------------------------| | Zimmer Dental | Tapered Screw-vent | 3.5, 4.5, 5.7 mm | | Nobel-Biocare | NobelReplace Select | 3.5, 4.3, 5.0 mm | | Biomet 3i | Osseotite Certain | 3.4, 4.1, 5.0 mm | | Lifecore | Renova (internal hex) | 3.5, 4.5 mm | | Biomedical | Restore (external hex) | 3.3, 4.1, 5.0 mm | Table A. Compatible Commercial Implant Manufacturers ### 3. Technological Characteristics: The AccuFit™ abutments and screws are made of Titanium alloy Ti6Al4V using the same fabrication procedures as those of the predicate devices. The Titanium alloy used conforms to the following standard: | Standard | Description | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | ASTM F136-08e1 | Standard Specification for Wrought Titanium-6 Aluminum-4<br>Vanadium ELI (Extra Low Interstitial) Alloy for Surgical<br>Implant Applications (UNS R56401) | #### 4. Comparison Analysis: The overall designs and technological characteristics of the AccuFit™ Abutment System are similar to that of the predicate devices. The materials used to manufacture the products and the indications for use are identical to the predicate devices. To ensure compatibility, the following process is carried out: - The commercially available implant components are purchased as samples. . {2}------------------------------------------------ # Berkeley implant = Precision Implant Technology ਾ 342 Raritan Center Parkway, Edison, New Jersey 08837 - The samples are measured using high-precision optical equipments, and the products are . machined using equipments capable of precision of um. - As a quality control step, the components produced are cross-assembled with the 0 commercially acquired samples. Screws are tightened to the amount of torque specified by the implant manufacturer. The interface between the components is then rechecked using the optical equipment to make sure precision fit is achieved. Berkeley Implant monitors the compatible implants for modifications to ensure future compatibility. In the event of any modification by the original manufacturers, Berkeley Implant will either modify the AccuFit" abutment to ensure compatibility, or cease claiming compatibility to the modified implants. The tables below summarize AccuFit" Abutments & Screws and the predicate devices' K numbers. | AccuFit Device | Predicate Device | K# for<br>Predicate | Material | |-------------------------------------------------------|-----------------------------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------| | Preformed, stock<br>Titanium<br>Abutments &<br>Screws | Zimmer Tapered Screw-vent Hex-lock<br>abutments & screws | K061410,<br>K011028 | Same as predicate devices:<br>Abutment - Titanium Alloy Ti6Al4V Screw - Titanium Alloy Ti6Al4V | | | Nobel-Biocare NobelReplace Select<br>Abutments and Screws | K021584 | | | | Biomet 3i GingiHue Post & Screw | K072642,<br>K063403 | | | | Lifecore Renova & Restore Abutments | K032774,<br>K965135 | | | | Diamodent Compatible Abutments | K034022,<br>K010619,<br>K993129 | | Table B: AccuFit TM Preformed Stock Abutments and Predicate Devices' K-numbers While some of the predicate devices use sterilized packaging and some do not, the AccuFit™ abutments use non-sterile packaging and provide detailed instructions on sterilizing procedures. # 5. CONCLUSION The evaluation of the AccuFit™ Abutment System does not raise any additional concerns regarding safety a d effectiveness and therefore is considered substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or sign. Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three intertwined snakes, and the text is in a simple, sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Ryan Chiou President Radiant Express LLC 342 Raritan Center Parkway Edison, New Jersey 08837 AUG 2 3 2010 Re: K101068 Trade/Device Name: AccuFit" Dental Implant Abutments and Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 5, 2010 Received: August 9, 2010 Dear Mr. Chiou: 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. {4}------------------------------------------------ #### Page 2- Mr. Chiou 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K101068 #### Statement of Indications for Use V. ## 510(k) Number (if known): K101068 Device Name: AccuFit™ Dental Implant Abutments and Screws Indications For Use: AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla. AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant. The AccuFit" Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes: Table A. Compatible Commercial Implant Manufacturers | Implant Company | Implant System | Implant Platform Diameter | |---------------------|------------------------|---------------------------| | Zimmer Dental | Tapered Screw-vent | 3.5, 4.5, 5.7 mm | | Nobel-Biocare | NobelReplace Select | 3.5, 4.3, 5.0 mm | | Biomet 3i | Osseotite Certain | 3.4, 4.1, 5.0 mm | | Lifecore Biomedical | Renova (internal hex) | 3.5, 4.5 mm | | | Restore (external hex) | 3.3, 4.1, 5.0 mm | Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Resin Mulvey for MSM (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K101068