# K101068: Accufit Dental Implant Abutments & Screws

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Express, LLC
- Decided: Aug 23, 2010 after 129 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 3.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001)
- K021584: Replace Scalloped Margin Implant System, Nobel Biocare Uas, Inc. (2002) Summary page 3.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 3.
- K063403: Conical Angled Abutment, Implant Innovations, Inc. (2007) Summary page 3.
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 3.
- K034022: Ucla and Cement-on Abutments and Accessories, Diamodent (2004) Summary page 3.
- K010619: Ucla and Universal Abutments, Diamodent (2001)
- K993129: Ucla/Universal Abutment, Diamodent (2000) Summary page 3.

## Cited in the summary but kept off the family tree
- K096513: Lifecore Renova & Restore Abutments. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
AccuFitTM 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. AccuFitTM Screws are intended for securing a abutment onto an endosseous dental implant. The AccuFitTM 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 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

Source page: https://510kreport.com/device/K101068
Methodology: https://510kreport.com/methodology