Enamel Pro
FDA 510(k) K062166 · Premier Dental Products Co.
510(k) numberK062166
Submission
- Device name
- Enamel Pro
- Applicant
- Premier Dental Products Co.
Plymouth Meeting, PA, US - Received
- July 28, 2006
- Decision date
- November 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powderEJR · Traditional | E.M.S Electro Medical Systems S.A | 09/11/2017SE |
| K131760 | Whip Mix Preppies PlusEJR · Traditional | Whip-Mix Corp. | 03/26/2014SE |
| K121698 | Nupro Sensodyne Prophylaxis Paste with NovaminEJR · Traditional | Dentsply International, Inc. | 08/06/2012SE |
| K103114 | Osspray Sylc CREJR · Traditional | Osspray, Ltd. | 03/14/2011SE |
| K102053 | Butler Calci-Flor Prophylaxis PasteEJR · Traditional | Sunstar Americas, Inc. | 02/03/2011SE |
| K101104 | Remin ProEJR · Traditional | Voco GmbH | 10/21/2010SE |
| K100539 | Preventech Prophylaxis Paste with FluorideEJR · Traditional | Preventive Technologies, Inc. | 06/17/2010SE |
| K070854 | GC Mi Paste PlusEJR · Special | GC America, Inc. | 04/12/2007SE |
| K062502 | Osspray Cleaning CompoundEJR · Traditional | Ospray, Ltd. | 12/15/2006SE |
| K042048 | Gelato Prophylaxis PasteEJR · Traditional | Deepak Products, Inc. | 10/26/2004SE |
More from Deepak Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | 03/03/2026SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | 11/07/2025SE |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | 12/06/2022SE |
| 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 |
| K062683 | Enamel Pro VarnishLBH · 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 cleared by the FDA?
Enamel Pro (K062166) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 116 days after the submission was received.
What is the product code of K062166?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.