Identifiers
- 510(k) Number
- K922615 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)
Coltene A.R.T. Bond is a dental restoration adhesive agent used for tooth bonding. It functions as a light-cured dentin-enamel bonding system.
This device is regulated under the dental specialty and has received FDA 510k authorization. It is intended for use as a two-step bonding system.
Frequently asked questions
What is the primary use of Coltene A.R.T. Bond?
Coltene A.R.T. Bond is a dental restoration adhesive agent specifically designed for tooth bonding. It functions as a light-cured system to facilitate the adhesion of restorative materials to dentin and enamel.
How is this bonding system applied?
This device is intended for use as a two-step bonding system. This process involves the application of the adhesive agent in two distinct stages to ensure proper bonding to the tooth structure.
Is this device authorized for clinical use?
Yes, Coltene A.R.T. Bond has received FDA 510k authorization. This indicates that the device has been reviewed and cleared for use within the dental specialty.
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: A.R.T. Bond | Online catalog - products.coltene.com, A.R.T. Bond | Online catalog - products.coltene.com, Dental restoration adhesive - A.R.T. Bond - Coltene Whaledent AG ..., RESTORATION - Coltene Whaledent AG - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K922615 | Class II | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- FDA Applicant
- Coltene/Whaledent, Inc.
Sources (1)
- FDA 510(k) K922615 24 fields · synced Sep 21, 2026