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Tuff-Temp 2.0

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120784

by Pulpdent Corporation

Identifiers

510(k) Number
K120784 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)

The Tuff-Temp 2.0 is a dual-cure, glass-filled resin composite material classified as a dental temporary prosthesis. It is designed for fabricating temporary crowns and bridges in clinical settings, providing a durable interim solution until permanent restorations can be completed.

This device is supplied in two components and requires both chemical and photo-initiators for polymerization. It is intended for single-use in dental offices and has received FDA 510(k) clearance under the Traditional review pathway. The product is regulated as a dental device under the U.S. regulatory framework, with no explicit mention of MRI safety or sterility requirements in the available data.

Frequently asked questions

What is the Tuff-Temp 2.0 used for in a dental office, and how does it differ from permanent restorations?

The Tuff-Temp 2.0 is a dual-cure, glass-filled resin composite specifically designed for creating temporary crowns and bridges. It serves as a durable interim solution to protect teeth and maintain function while patients await their permanent restorations. Unlike permanent restorations, it is not intended for long-term use and requires replacement once the final restoration is ready.

Is the Tuff-Temp 2.0 meant for reuse, or is it single-use only?

The Tuff-Temp 2.0 is explicitly intended for single-use in dental offices. This ensures patient safety and material consistency, as reuse could compromise the integrity of the temporary restoration.

How is the Tuff-Temp 2.0 supplied, and what components are required for use?

The Tuff-Temp 2.0 is supplied as a two-component system. Both components are necessary for polymerization, which requires both chemical and photo-initiators to fully cure the material. This dual-cure mechanism allows for flexibility in clinical application, whether light-activated or self-curing.

What regulatory pathway was followed for the FDA clearance of the Tuff-Temp 2.0?

The Tuff-Temp 2.0 received FDA clearance under the Traditional 510(k) review pathway, determined to be substantially equivalent to a legally marketed predicate device. The decision was made by the Dental (DE) Advisory Committee, and the clearance was granted on June 8, 2012.

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: TUFF-TEMP 2.0 (K120784) — FDA 510(k) | Innolitics, PDF th(2 o791JN-822 - Food and Drug Administration, Tuff-temp 2.0 510 (k) FDA Premarket Notification K120784 PULPDENT ..., PDF Safety Data Sheet - PULPDENT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K120784 24 fields · synced Sep 18, 2026