Scotchbond Dental Adhesive
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K813180 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 Scotchbond Dental Adhesive is a dental adhesive used for tooth bonding. It is a resin-based adhesive.
The device is supplied as a single component and is intended for use in dental applications. It has been authorized with an FDA 510K clearance and is classified as a class 2 device. The device is registered with various registration numbers and has a regulation number of 872.3200.
Frequently asked questions
What is the Scotchbond Dental Adhesive used for?
The Scotchbond Dental Adhesive is used for tooth bonding in dental applications.
Is the Scotchbond Dental Adhesive supplied sterile?
The device data does not specify if the Scotchbond Dental Adhesive is supplied sterile, it is recommended to follow the manufacturer's instructions for use.
What is the regulatory status of the Scotchbond Dental Adhesive?
The Scotchbond Dental Adhesive has been authorized with an FDA 510K clearance and is classified as a class 2 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: 3M™ Scotchbond™ Universal Adhesive - solventum.com, 3M™ Scotchbond™ Universal Plus Adhesive, PDF 3M Scotchbond Universal Plus Adhesive The original, now better than ever!
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K813180 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K813180 24 fields · synced Sep 21, 2026