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Temrex Etching Gel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872569

by Scientific Pharmaceuticals, Inc.

Identifiers

510(k) Number
K872569 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Temrex Etching Gel is a dental device classified as an etching agent for dental applications, designed to prepare tooth surfaces for adhesive restorative procedures. It is composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) and is intended for use in dental restorative treatments, including the conditioning of enamel prior to bonding agents or composite resin applications. The gel works by creating a micro-retentive surface on the tooth structure, enhancing adhesion and durability of restorative materials. Its primary function is to improve the bond strength between dental restorations and natural tooth tissue.

Temrex Etching Gel is supplied as a single-use dental product and is regulated under FDA 510(k) clearance (K872569) as a dental device. It is intended for use in clinical dental settings, where it is applied directly to the tooth surface using a brush or similar applicator. The product is non-sterile as supplied and must be used in accordance with standard dental practice protocols. No specific MRI safety information is provided, and it is classified under product code EBF for dental etching agents. Storage conditions are not detailed but typically require protection from moisture and extreme temperatures.

Frequently asked questions

What is Temrex Etching Gel used for in dental procedures?

Temrex Etching Gel is designed to prepare tooth surfaces for adhesive restorative treatments. It creates a micro-retentive surface on enamel, which significantly improves the bond strength between dental restorations (like composite resins) and natural tooth tissue. This ensures longer-lasting and more durable restorations by promoting better adhesion of bonding agents.

Is Temrex Etching Gel sterile as supplied, and how should it be used?

Temrex Etching Gel is non-sterile as supplied, meaning it must be used in a clinical setting where standard dental aseptic protocols are already in place. It is intended for single-use applications only. The gel is applied directly to the tooth surface using a brush or similar applicator, following standard dental practice guidelines for etching and bonding procedures.

What are the key differences between Temrex Etching Gel and other dental etching agents?

Temrex Etching Gel is formulated with bisphenol-A glycidyl methacrylate (Bis-GMA), a material commonly used in dental adhesives, which helps optimize enamel conditioning for composite restorations. Unlike some alternatives, it is explicitly FDA 510(k)-cleared (K872569) under product code EBF for dental etching agents, ensuring compliance with U.S. regulatory standards. Its primary distinction lies in its role in enhancing adhesion durability for restorative materials.

How should Temrex Etching Gel be stored, and what precautions should be taken?

While specific storage instructions aren’t detailed in the product documentation, dental etching gels like Temrex Etching Gel typically require protection from moisture and extreme temperatures to maintain efficacy. Store in a cool, dry place, away from direct sunlight or sources of heat. Ensure the container is tightly sealed when not in use to prevent contamination or degradation of the gel’s adhesive properties.

Can Temrex Etching Gel be reused, and what is its intended clinical setting?

Temrex Etching Gel is intended for single-use only in clinical dental settings. Reuse is not recommended, as repeated exposure to moisture or contamination could compromise its effectiveness in creating a reliable micro-retentive surface for bonding. It is designed exclusively for professional use by dentists or dental hygienists during restorative procedures.

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: TEMREX ETCHING GEL (K872569) — FDA 510 (k) | Innolitics, PDF K872569 TEMREX ETCHING GEL - 510kdatabase.net, Welcome to Sci-Pharm, Device Listing 1787490645 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K872569 24 fields · synced Oct 1, 2026