# K101607: Biomet 3I Patient Specific Dental Abutments - Encode Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Mar 11, 2011 after 276 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 K944964 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 1.
- K052648: Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars, Implant Innovations, Inc. (2005) Summary page 1.

## Indications for use
Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Source page: https://510kreport.com/device/K101607
Methodology: https://510kreport.com/methodology