Preventech Prophylaxis Paste with Fluoride
FDA 510(k) K100539 · Preventive Technologies, Inc.
510(k) numberK100539
Submission
- Device name
- Preventech Prophylaxis Paste with Fluoride
- Applicant
- Preventive Technologies, Inc.
Indian Trial, NC, US - Received
- February 25, 2010
- Decision date
- June 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K070854 | GC Mi Paste PlusEJR · Special | GC America, Inc. | 04/12/2007SE |
| K062502 | Osspray Cleaning CompoundEJR · Traditional | Ospray, Ltd. | 12/15/2006SE |
| K062166 | Enamel ProEJR · Traditional | Premier Dental Products Co. | 11/21/2006SE |
| K042048 | Gelato Prophylaxis PasteEJR · Traditional | Deepak Products, Inc. | 10/26/2004SE |
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Questions and answers
When was Preventech Prophylaxis Paste with Fluoride cleared by the FDA?
Preventech Prophylaxis Paste with Fluoride (K100539) received a 510(k) decision of Substantially Equivalent on June 17, 2010, 112 days after the submission was received.
What is the product code of K100539?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.