3M Quikplus System
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K970168 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a temporary crown and bridge resin, classified under product code EBG. It is intended for use in dental applications as a temporary restorative material.
The 3M Quikplus System is supplied as a Class II medical device with special controls. It received FDA 510(k) clearance (K970168) on February 27, 1997, and is manufactured by 3M Company in St. Paul, Minnesota, United States.
Frequently asked questions
What is the 3M Quikplus System used for?
The 3M Quikplus System is intended for use in dental applications as a temporary restorative material, specifically for temporary crown and bridge restorations, based on its classification under product code EBG.
How is the 3M Quikplus System supplied and is it sterile or single-use?
The device is supplied as a temporary crown and bridge resin; however, the provided data does not specify sterility, single-use, or reuse characteristics, so these details cannot be confirmed from the available information.
What regulatory pathway was used for the 3M Quikplus System?
The 3M Quikplus System received FDA 510(k) clearance under the traditional pathway, with clearance granted on February 27, 1997, under K970168, and is classified as a Class II device with special controls.
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: K970168 - 3M QUIKPLUS SYSTEM | FDA 510(k) | 3M Company, PDF K970168 - 3m Quikplus System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970168 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K970168 24 fields · synced Sep 22, 2026