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Protemp 3 Garant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033022

by 3M Espe AG Dental Products

Identifiers

510(k) Number
K033022 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Protemp 3 Garant is a composite-based dental material classified as a dental resin for temporary restorations (product code EBG). It is designed for fabricating provisional crowns, bridges, inlays, onlays, and veneers, offering enhanced strength, polishability, and fracture resistance. The self-curing material provides a durable temporary solution for dental prostheses during restorative treatment planning.

This material is supplied in the Garant mixing and dispensing system for chairside use. It is intended for single-use applications in dental offices and is not sterile at time of supply. The device holds an FDA 510(k) clearance (K033022) under the Traditional 510(k) review pathway, with a decision date of November 21, 2003. No MRI safety or reusable design information is specified.

Frequently asked questions

What types of temporary dental restorations can the Protemp 3 Garant material be used for in a clinical setting?

The Protemp 3 Garant is specifically designed for creating temporary dental restorations such as provisional crowns, bridges, inlays, onlays, and veneers. Its composite-based formula provides enhanced strength, polishability, and fracture resistance, making it suitable for chairside fabrication during restorative treatment planning.

How is the Protemp 3 Garant material supplied, and is it intended for single-use or reuse?

The Protemp 3 Garant is supplied in the Garant mixing and dispensing system, which is intended for single-use applications in dental offices. It is not sterile at the time of supply, so it must be handled and prepared under appropriate clinical conditions.

Does the Protemp 3 Garant material require any special storage conditions, and what should clinicians consider when handling it?

While the provided data does not specify exact storage conditions, the material is self-curing and intended for chairside use in dental offices. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.

What regulatory pathway was followed for the FDA clearance of the Protemp 3 Garant, and when was the decision made?

The Protemp 3 Garant received FDA clearance through the Traditional 510(k) review pathway under the Dental advisory committee (DE). The clearance decision was made on November 21, 2003, with the submission received on September 25, 2003, and the device was determined to be substantially equivalent to a predicate.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3M™ ESPE Protemp 3 Garant Temporization Material (abridged) - Dental ..., PROTEMP 3 GARANT (K033022) — FDA 510 (k) | Innolitics, PDF Protemp(TM) 3 Garant(TM) Temporization Material

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3M Espe AG Dental Products

Sources (1)

  • FDA 510(k) K033022 24 fields · synced Oct 6, 2026