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Denture Teeth, Plastic

by Dentsply Intl.

510(k) K792245

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792245 Date4 Jan 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Teeth, Denture, Plastic
510(k) Number
FDA Product Code
ELM
Device Class
Class II
Regulation
21 CFR Part 872.3590
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a denture tooth, a prosthetic component designed to replace missing natural teeth in removable dentures. Made from plastic, these teeth are custom-fitted to restore function and aesthetics in partial or full dentures, aligning with the classification of teeth, denture, plastic under FDA nomenclature.

Denture teeth are supplied as reusable, non-sterile components intended for use in dental laboratories or by dentists. They are classified as Class II devices under FDA regulations (21 CFR 872.3590) and require a 510(k) clearance, as evidenced by the K792245 submission. Multiple reference codes (e.g., 3009541709, 1000269600) identify variations in size, shade, and mould, ensuring compatibility with different denture designs.

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