# K992854: Artificial Teeth (Acrylic Teeth)

- Pathway: 510(k) (Traditional)
- Applicant: Masterdent Ltda.
- Decided: Feb 7, 2000 after 167 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- 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
ACRYLIC TEEHT ARE USE FOR MAKING,FULL AND PARTIAL DENTURES. THE ACRYLIC TEEHT ARE MOUNTED -ON A APPLIANCE,MADE OF DENTAL ACRYLIC. ONCE THAT APPLIANCE IS MADE IS FITTED IN TO PATIENT MOUTH. THIS APPLIANCE IS REMOVABLE, IS NOT IMPLANTED.

Source page: https://510kreport.com/device/K992854
Methodology: https://510kreport.com/methodology