# K022032: Acetal

- Pathway: 510(k) (Traditional)
- Applicant: Inovativ, LLC
- Decided: Aug 29, 2002 after 69 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. The FDA summary names its predicate without a number.
- (no number) Pressing North America, Inc. "Acetal Dental" Acetal resin: named in the summary without a submission number

## Indications for use
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.

Source page: https://510kreport.com/device/K022032
Methodology: https://510kreport.com/methodology