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Renamel Bulkfill

by Cosmedent, Inc.

510(k) K211259

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211259 Date24 Jun 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 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  • Withdrawn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, 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.

Renamel Bulkfill is a dental composite material classified under the traditional panel dental device type. It is intended for use in restorative dental procedures, providing a packable, sculptable, and polishable material for posterior restorations.

The product was cleared by the FDA on 2021-06-24 through a traditional 510(k) submission (K211259) and is identified by product code EBF. It is supplied by Cosmedent, Inc. in Chicago, IL, United States, and is referenced as a single composite kit without additional sterility or single‑use specifications in the available data.

From the manufacturer

Renamel BULKfill Kit New Renamel BULKfill is fast, packable, and polishable! The post Renamel BULKfill Dental Compositeappeared first on Cosmedent.

Source: cosmedent.com

Manufacturer's product page: Renamel Bulkfill

Other devices from Cosmedent, Inc.

See all devices from Cosmedent, Inc. →

Questions

AI-generated answers, 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.

  • What is Renamel Bulkfill used for in dental procedures?

    Renamel Bulkfill is a dental composite material designed for restorative dental procedures, specifically for posterior restorations. It provides a packable, sculptable, and polishable material that dentists can use to fill and restore teeth in the back of the mouth.

  • How is Renamel Bulkfill supplied and what are its specifications?

    Renamel Bulkfill is supplied as a single composite kit by Cosmedent, Inc. in Chicago, IL. The available data does not specify additional sterility requirements or single-use designations, indicating it may be handled according to standard dental composite protocols.

  • What is the regulatory status of Renamel Bulkfill?

    Renamel Bulkfill was cleared by the FDA on June 24, 2021, through a traditional 510(k) submission with K number K211259. It is classified under product code EBF and was determined to be substantially equivalent to predicate devices for dental restorative applications.

  • What distinguishes Renamel Bulkfill from other dental composites?

    Renamel Bulkfill is distinguished by its specific formulation designed for posterior restorations, offering packable, sculptable, and polishable properties. Its unique characteristics and FDA clearance through 510(k) K211259 differentiate it from other composite materials in the dental market.