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TEMPHASE

by Kerr Dental Materials Center 510(k)

Active United States

510(k) K020092

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020092 Date22 Feb 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

TEMPHASE is a two component bis-methacryl-type composite material designed for short and long term provisional crown and bridge restorations. It is 41% filled with the same material as Prodigy and Herculite, with an average particle size of 0.6 microns, offering high strength, low wear, and excellent polishability that minimizes gingival irritation.

TEMPHASE is offered in regular and fast set formulations, has improved handling properties, and exhibits a reduced oxygen inhibited layer. It is supplied as a dental restorative material for provisional use, with FDA 510(k) clearance under K020092, and is manufactured by Kerr Dental Materials Center.

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Questions

AI-generated answers, 25 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 TEMPHASE used for?

    TEMPHASE is designed for short and long term provisional crown and bridge restorations, providing a durable, polishable temporary restoration that minimizes gingival irritation due to its high strength, low wear, and excellent surface finish.

  • How is TEMPHASE supplied and what are its formulations?

    TEMPHASE is supplied as a two-component bis-methacryl-type composite material in regular and fast set formulations, offering improved handling properties and a reduced oxygen inhibited layer for easier clinical use.

  • Is TEMPHASE sterile or single-use?

    TEMPHASE is a dental restorative material supplied non-sterile for provisional use; it is intended for single-patient use during the fabrication of temporary crowns and bridges, not for reuse after placement.

  • What are the key material specifications of TEMPHASE?

    TEMPHASE is 41% filled with the same filler as Prodigy and Herculite, featuring an average particle size of 0.6 microns, which contributes to its high strength, low wear, and excellent polishability for provisional restorations.