# K983558: Acetal Dental/Preformed Clasp

- Pathway: 510(k) (Traditional)
- Applicant: Dentamax, Inc.
- Decided: Jan 7, 1999 after 86 days
- Product code: EHP (Clasp, Preformed)
- Device class: 1
- Regulation: 21 CFR 872.3285
- 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
Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.

Source page: https://510kreport.com/device/K983558
Methodology: https://510kreport.com/methodology