Tooth Bonding Agent
FDA 510(k)Class II (US FDA 510(k))
by VOCO GmbH
Identifiers
- 510(k) Number
- K920365 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)
A tooth bonding agent is a dental device used to facilitate adhesion between tooth structure and restorative materials. It functions as an adhesive system that requires separate etching of the tooth surface prior to application.
The device is supplied as a dental adhesive system and is intended for use in dental restorative procedures. It received FDA 510(k) clearance under K920365 with product code EBF and was determined to be substantially equivalent to a legally marketed device. The authorization is based on a traditional review pathway, and no claims about sterility, single-use status, MRI safety, sizes, or storage are present in the provided data.
Frequently asked questions
What is the TOOTH BONDING AGENT used for?
The TOOTH BONDING AGENT is a dental device used to facilitate adhesion between tooth structure and restorative materials, functioning as an adhesive system that requires separate etching of the tooth surface prior to application in dental restorative procedures.
How is the TOOTH BONDING AGENT supplied?
The device is supplied as a dental adhesive system, as stated in the description, though specific packaging, volume, or format details are not provided in the data.
Is the TOOTH BONDING AGENT sterile or single-use?
The provided data does not contain any information about sterility or single-use status for the TOOTH BONDING AGENT, so these characteristics cannot be confirmed from the available specifications.
What regulatory pathway was used for the TOOTH BONDING AGENT?
The TOOTH BONDING AGENT received FDA 510(k) clearance under K920365 through a traditional review pathway and was determined to be substantially equivalent to a legally marketed device.
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: Bonding | VOCO GmbH, Futurabond U - Bonding | VOCO GmbH, voco bond | Benco Dental, VOCO Quality Dental Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920365 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA 510(k) K920365 24 fields · synced Oct 6, 2026