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Premier Temporary Cement

by Premier Dental Products Co.

510(k) K051866

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 NumberK051866 Date6 Sep 2005ClearedStatusActive

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  • Withdrawn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, 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.

This dental cement is classified as a Cement, Dental (FDA Device Class II) and serves as a temporary restorative material used in dental procedures. It provides firm retention for interim dental restorations, such as crowns or bridges, ensuring stability between patient visits while maintaining biocompatibility with oral tissues.

The cement is supplied as a 5 mL Automix Syringe paired with 10 mixing tips, available in both opaque and clear shades. It is intended for single-use applications in dental settings and has received FDA 510(k) clearance under the Traditional pathway. No regulatory status beyond the provided authorization is implied.

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Questions

AI-generated answers, 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.

  • What is the Premier Temporary Cement primarily used for in dental procedures?

    The Premier Temporary Cement is designed as a temporary restorative material to provide firm retention for interim dental restorations, such as crowns or bridges. It ensures stability between patient visits while maintaining biocompatibility with oral tissues, making it ideal for short-term use until permanent restorations can be placed.

  • How is the Premier Temporary Cement supplied, and what accessories come with it?

    The cement is supplied as a 5 mL Automix Syringe, which includes a built-in mixing system for convenience. It comes paired with 10 mixing tips, allowing for precise application in dental procedures. The syringe is intended for single-use only, ensuring sterility and safety.

  • Is the Premier Temporary Cement reusable, or is it meant for single-use only?

    The Premier Temporary Cement is explicitly designed for single-use applications in dental settings. This ensures sterility and reduces the risk of cross-contamination, which is critical in clinical environments where hygiene is paramount.

  • What regulatory pathway was followed for the FDA clearance of the Premier Temporary Cement?

    The Premier Temporary Cement received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance is specific to its classification as a Class II Dental Cement.

  • Are there different shades available for the Premier Temporary Cement, and how might this affect its use?

    Yes, the Premier Temporary Cement is available in both opaque and clear shades. The choice of shade can help match the natural appearance of the patient’s teeth, improving aesthetics during the interim period until permanent restorations are placed. This customization ensures a more comfortable and visually acceptable temporary solution.