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Glass Ionomer Cement

by Confi-Dental Products Co.

510(k) K914318

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 NumberK914318 Date20 Mar 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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Glass Ionomer Cement is a dental cement used for restorative and luting procedures in dentistry. It is classified as a Class II medical device under product code EMA and regulation number 872.3275.

The device was cleared by the FDA through the traditional 510(k) pathway under K914318, with a decision date of March 20, 1992. It is manufactured by Confi-Dental Products Co. located in Louisville, Colorado, and is supplied as a non-sterile, reusable or single-use material depending on formulation and clinical use, with no MRI safety claims or specific storage conditions stated in the provided data.

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