# K090630: Nobel Biocare Endosseous Implants (Maxillofacial Indication)

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 2, 2009 after 85 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945154 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945154: BA-Cpas, Nobelpharma USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K161548: Osseointegrated Fixtures (2016), 1 descendant of its own
- K241253: Medicon Epiplating System (2024), 0 descendants of its own

## Indications for use
Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

Source page: https://510kreport.com/device/K090630
Methodology: https://510kreport.com/methodology