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Hydroxylate Dental Composite Restroative

by Wallace A. Erickson & Co.

510(k) K802535

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 NumberK802535 Date18 Dec 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  • Withdrawn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)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
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.

The Hydroxylate Dental Composite Restorative is a dental restorative material classified under the nomenclature for composite resins (21 CFR 872.3690). It is designed for filling and restoring dental cavities, providing a durable and aesthetically integrated solution for posterior and anterior teeth.

This device is supplied as a single-use dental composite and requires proper handling and storage in accordance with manufacturer guidelines. It is intended for use in clinical settings by dental professionals and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of December 18, 1980. The product code assigned is EBF, and it falls under the Dental advisory committee classification.

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