# K990458: Straumann Extraoral Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Apr 16, 1999 after 63 days
- Product code: KCZ (Prosthesis, Breast, External, Used With Adhesive)
- Device class: 1
- Regulation: 21 CFR 878.3800
- 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). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K945154: BA-Cpas, Nobelpharma USA, Inc. (1995) Summary page 1.
- K961719: Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K912521: Dental Implant System 4.0MM and 5.5MM Length, Bud Industries, 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
The Straumann Extraoral implant is an endosseous implant intended for placement in the skull, mainly in the mastoid process, periorbital, and perinasal regions. Its purpose is to provide rigid retention for craniomaxillofacial epitheses such as eye, ear and nose epitheses.

Source page: https://510kreport.com/device/K990458
Methodology: https://510kreport.com/methodology