# K972198: Dent-Temp Acrylic

- Pathway: 510(k) (Traditional)
- Applicant: Health-Dent Intl., Inc.
- Decided: Dec 17, 1997 after 189 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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
DENT-TEMP™ ACRYLIC is a self-curing svstem. It is available in three Vita-Shades, A-1, A-2. A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPT™ LIQUID used with powders, made out of Memhyimethacrylate Monomer. DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish. polymer system can be used.

Source page: https://510kreport.com/device/K972198
Methodology: https://510kreport.com/methodology