# K130310: Certain Bellatek Provisional Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i
- Decided: Jun 21, 2013 after 134 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: 4 generations back to K871954 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 1.
- K071551: Quickbridge TM Cylinder and Cap, Biomet 3i, Inc. (2007)
- K061177: Provide Temporary Cylinder, Implant Innovations, Inc. (2006) Summary page 1.
- K060291: Preformance Temporary Cylinder, Implant Innovations, Inc. (2006) Summary page 1.

## Indications for use
Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of provisional restorations. The prosthesis will be mechanically retained to the abutment system.

Source page: https://510kreport.com/device/K130310
Methodology: https://510kreport.com/methodology