# K220339: Esthetic Abutments Nobel Biocare N1

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Services AG
- Decided: Sep 16, 2022 after 221 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: 8 generations back to K894595 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 5.
- K161655: On1 Concept, Nobel Biocare AB (2017) Summary page 5.

## Indications for use
Esthetic Abutment Nobel Biocare Nl TM TCC: The Esthetic Abutment Nobel Biocare Nl TM TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare Nl TM Base: The Esthetic Abutment Nobel Biocare Nl TM Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.

Source page: https://510kreport.com/device/K220339
Methodology: https://510kreport.com/methodology