Identifiers
- 510(k) Number
- K942017 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)
V-Primer is a resin tooth bonding agent classified as a dental device. It is designed for priming noble and precious alloys without the need for tin plating.
This device is supplied in a 3ml bottle. It is authorized for use under FDA 510(k) clearance K942017.
Frequently asked questions
What is the primary purpose of V-Primer?
V-Primer is a resin tooth bonding agent used in dental procedures to prime noble and precious alloys. It is specifically designed to facilitate bonding without requiring the clinician to perform tin plating.
How is this device supplied?
V-Primer is supplied by Parkell, Inc. in a 3ml bottle for clinical use.
What is the regulatory status of V-Primer?
V-Primer is authorized for use under FDA 510(k) clearance number K942017. This indicates the device has been reviewed and cleared for the market through the traditional 510(k) process.
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: V-PRIMER (K942017) — FDA 510 (k) | Innolitics, TotalBond V-Primer 3ml Bottle (Parkell) - skydentalsupply.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942017 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA 510(k) K942017 24 fields · synced Sep 22, 2026