# K212730: BellaTek Encode Emergence Healing Abutments

- Pathway: 510(k) (Special)
- Applicant: Biomet 3i, LLC
- Decided: Dec 21, 2021 after 113 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: 3 generations back to K072642 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173374: TSV BellaTek Encode Healing Abutments, Biomet 3i (2017) Summary page 4.

## Indications for use
The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

Source page: https://510kreport.com/device/K212730
Methodology: https://510kreport.com/methodology