# K081157: Accuframe

- Pathway: 510(k) (Traditional)
- Applicant: Cagenix, Inc.
- Decided: Jul 22, 2008 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100356: TDS Precision Dental Bar (2010), 0 descendants of its own

## Indications for use
AccuframeTM is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

Source page: https://510kreport.com/device/K081157
Methodology: https://510kreport.com/methodology