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Modified TempRx Esthetic Provisional System

by Dentsply Interntional

510(k) K080311

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 NumberK080311 Date18 Apr 2008ClearedStatusActive

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  • Withdrawn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
EBG
Device class
Class II
Regulation
21 CFR Part 872.3770
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 Modified TempRx Esthetic Provisional System is a visible light-cured composite-based resin system classified as a dental provisional restoration device. It is designed for fabricating temporary crowns, bridges, inlays, onlays, veneers, and tooth build-ups on denture bases, providing durable and aesthetically pleasing interim restorations in clinical dental settings.

This system is intended for single-use in dental offices and clinics. It is supplied as a composite resin kit requiring light-curing for polymerization. The device holds an FDA 510(k) clearance under the Traditional pathway, with a K-number of K080311 and product code EBG, and is regulated under the classification for dental restorative items (872.3770). No information regarding sterility or MRI safety is provided in the specifications.

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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 types of dental restorations can the Modified TempRx Esthetic Provisional System be used for?

    The Modified TempRx Esthetic Provisional System is specifically designed for creating temporary dental restorations, including crowns, bridges, inlays, onlays, veneers, and tooth build-ups on denture bases. It is intended for use in clinical settings where durable, aesthetically pleasing interim solutions are required before permanent restorations are placed.

  • Is the Modified TempRx Esthetic Provisional System intended for reuse or single-use?

    The Modified TempRx Esthetic Provisional System is explicitly intended for single-use in dental offices and clinics. This ensures patient safety and hygiene standards are maintained, as the system is not designed for repeated applications.

  • How is the Modified TempRx Esthetic Provisional System supplied, and what process is required for use?

    The system is supplied as a composite resin kit that requires visible light-curing for polymerization. This means the material must be applied to the prepared tooth structure and then cured under a dental curing light to harden and form the provisional restoration.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The Modified TempRx Esthetic Provisional System received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for dental provisional restorations.