# K072642: Biomet 3I Dental Abutments and Restorative Components - Pathway: 510(k) (Traditional) - Applicant: Biomet 3i, Inc. - Decided: Dec 20, 2007 after 93 days - Product code: NHA (Abutment, Implant, Dental, Endosseous) - Device class: 2 - Regulation: 21 CFR 872.3630 - Recalls of this device: 81 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 256 later devices descend from it; 12 cite it directly. 0 of 257 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) UCLA: named in the summary without a submission number - (no number) Gingehue: named in the summary without a submission number - (no number) Certain Provide: named in the summary without a submission number - (no number) Pre-Angled Abutments: named in the summary without a submission number - (no number) Conical Abutments: named in the summary without a submission number - (no number) Tapered Abutments: named in the summary without a submission number - (no number) Temporary Healing Abutments: named in the summary without a submission number - (no number) Abutment Posts: named in the summary without a submission number - (no number) Rocket II Abutments: named in the summary without a submission number - (no number) IOL Abutments: named in the summary without a submission number ## Most influential descendants - K100152: Sirona Cad/Cam System (2010), 240 descendants of its own - K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own - K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own - K150367: Neodent Implant System (2015), 89 descendants of its own - K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own ## Recalls of this device - Jan 10, 2020 · Class II · Z-1366-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1378-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1375-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1371-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1368-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1384-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1385-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1386-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1379-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1382-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1373-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1388-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1387-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1367-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1369-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1374-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1372-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1370-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1377-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1380-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1383-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1381-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Jan 10, 2020 · Class II · Z-1376-2020: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment - Nov 25, 2015 · Class II · Z-2499-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2486-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2464-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2515-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2450-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2506-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2445-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2494-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2456-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2468-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2524-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2418-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2466-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2409-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2412-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2439-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2476-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2449-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2417-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2407-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2507-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2406-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2503-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2413-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2512-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2474-2016: Pouches may not have been sealed during packing. - Nov 25, 2015 · Class II · Z-2509-2016: Pouches may not have been sealed during packing. ## Indications for use BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. Restorative Components * Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing. * Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dental prosthetics. * Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to the dental implant. Source page: https://510kreport.com/device/K072642 Methodology: https://510kreport.com/methodology