# K223677: Titanium Abutment Blank Nobel Biocare N1 TCC

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Apr 28, 2023 after 141 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: 18 generations back to K894844 (1990). 176 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222044: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2022) Summary page 4.

## Most influential descendants
- K250178: Adin Customized Abutments (2025), 0 descendants of its own

## Indications for use
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K223677
Methodology: https://510kreport.com/methodology
