Skip to content

Isosit Teeth

by Bauer, Cheng & Associates, Inc.

510(k) K810970

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 NumberK810970 Date5 May 1981ClearedStatusActive

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  • Withdrawn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)

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, 27 Sep 2026

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

Isosit Teeth are plastic denture teeth designed for use in dental prosthetics. These artificial teeth are intended to serve as functional components in the construction of dentures.

This device is classified as a Class 2 medical device under regulation 872.3590. It has received FDA 510(k) clearance, identified by the number K810970.

Other devices from Bauer, Cheng & Associates, Inc.

  • Coltene Brilliant

    Class II

  • Rx 91

    Class II

  • Isosit C & B Material

    Class II

  • Naturelle

    Class II

  • Challenger

    Class II

  • Rex-Caps

    Class II

See all devices from Bauer, Cheng & Associates, Inc. →