# K080397: American Dental Implant Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Implant Corporation
- Decided: May 6, 2008 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.

Source page: https://510kreport.com/device/K080397
Methodology: https://510kreport.com/methodology