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New Tooth Material

by Dentsply Intl.

510(k) K920684

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 NumberK920684 Date23 Dec 1992ClearedStatusActive

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  • Withdrawn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.

Denture, Plastic, Teeth is a device used in dental applications for the replacement of missing teeth in prosthetic dentures. It is classified as a Class II medical device under FDA regulation 872.3590 with product code ELM.

The device was cleared via the FDA 510(k) pathway under K920684 on December 23, 1992, following a traditional review. It is manufactured by Dentsply Intl. and is supplied as a non-sterile, reusable or single-use component depending on the final prosthesis design, with no MRI safety information provided in the data.

Other devices from Dentsply Intl.

See all devices from Dentsply Intl. →

Questions

AI-generated answers, 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.

  • What is the NEW TOOTH MATERIAL device used for?

    The NEW TOOTH MATERIAL device, identified as Denture, Plastic, Teeth, is used in dental applications for the replacement of missing teeth in prosthetic dentures, as stated in the device description.

  • How is the NEW TOOTH MATERIAL supplied and is it sterile or single-use?

    The device is supplied as a non-sterile component and can be either reusable or single-use, depending on the final prosthesis design, with no indication of sterility or mandatory single-use labeling in the provided data.

  • What regulatory pathway was used to clear the NEW TOOTH MATERIAL and when was it cleared?

    The device was cleared via the FDA 510(k) pathway under submission K920684 on December 23, 1992, following a traditional review process, as specified in the authorization and decision details.