Identifiers
- 510(k) Number
- K020239 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)
Touch&Bond-Plus is a resin tooth bonding agent used as a dentin bonding system. It is classified as a dental device intended for use in dental procedures.
This device is regulated as a Class 2 medical device under regulation number 872.3200. It received FDA 510(k) clearance through the traditional pathway.
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: K020239 - TOUCH&BOND-PLUS | FDA 510 (k) | Parkell, Inc., TOUCH&BOND-PLUS 510 (k) K020239 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020239 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA 510(k) K020239 24 fields · synced Sep 26, 2026