Enamel Pro Varnish
FDA 510(k) K062683 · Premier Dental Products Co.
510(k) numberK062683
Submission
- Device name
- Enamel Pro Varnish
- Applicant
- Premier Dental Products Co.
Plymouth Meeting, PA, US - Received
- September 8, 2006
- Decision date
- November 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | 08/26/2013SE |
| K083695 | TraxodentMVL · Traditional | 04/28/2009SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
| K061997 | Premier Self-Etching Enamel SealantEBC · Traditional | 10/04/2006SE |
Questions and answers
When was Enamel Pro Varnish cleared by the FDA?
Enamel Pro Varnish (K062683) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 74 days after the submission was received.
What is the product code of K062683?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.