Identifiers
- 510(k) Number
- K120213 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Etch-Rite Supreme is a dental agent classified as a Tooth Bonding Resin Etchant, designed to prepare enamel and dentin surfaces for bonding procedures. It contains 36% phosphoric acid in gel form, enabling controlled etching to enhance adhesion in restorative treatments.
This single-use, non-sterile gel is supplied in a syringe for precise application in dental settings. It requires no special storage conditions and is intended for use by dental professionals. The device holds an FDA 510(k) clearance under classification II (K120213) and adheres to regulation 872.3200.
Frequently asked questions
What is the Etch-Rite Supreme used for in dental procedures, and why is the 36% phosphoric acid concentration important?
The Etch-Rite Supreme is a tooth bonding resin etchant designed to prepare enamel and dentin surfaces for bonding procedures, such as restorative treatments like fillings or crowns. The 36% phosphoric acid concentration in gel form enables controlled etching, which roughens the tooth surface to enhance adhesion of bonding agents. This controlled acidity ensures effective bonding without damaging the underlying tooth structure.
How is the Etch-Rite Supreme supplied, and is it intended for single-use only?
The Etch-Rite Supreme is supplied in a syringe, which allows for precise application in dental settings. It is explicitly labeled as a single-use product, meaning each syringe should be used once and then discarded to maintain sterility and performance standards.
Does the Etch-Rite Supreme require any special storage conditions, and why?
No, the Etch-Rite Supreme does not require special storage conditions. Since it is non-sterile and designed for single-use, it can be stored under standard dental office conditions, ensuring accessibility and ease of use without compromising its intended function.
What regulatory pathway was followed for the FDA clearance of the Etch-Rite Supreme, and what does this mean for dental professionals?
The Etch-Rite Supreme holds an FDA 510(k) clearance under classification II (K120213), meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. This clearance indicates that the device meets FDA safety and effectiveness standards for use as a tooth bonding resin etchant, providing dental professionals with confidence in its regulatory compliance and suitability for bonding 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: Etch-Rite™ - PULPDENT, ETCH-RITE SUPREME by PULPDENT CORPORATION | FDA 510(k) Summary, Etch-rite Supreme 510 (k) FDA Premarket Notification K120213 PULPDENT ..., Etch Rite (Pulpdent) | Sky Dental Supply
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120213 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K120213 24 fields · synced Sep 18, 2026