Propol Dental Polishing Paste
FDA 510(k) K852489 · Scientific Pharmaceuticals, Inc.
510(k) numberK852489
Submission
- Device name
- Propol Dental Polishing Paste
- Applicant
- Scientific Pharmaceuticals, Inc.
Duarte, CA, US - Received
- June 7, 1985
- Decision date
- July 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K062166 | Enamel ProEJR · Traditional | Premier Dental Products Co. | 11/21/2006SE |
More from Premier Dental Products Co.
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| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…LBH · Traditional | 02/18/2020SE |
| K051952 | EugenoneEMA · Traditional | 09/07/2005SE |
| K041886 | ProvisoEBG · Traditional | 08/04/2004SE |
| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
| K001446 | Light-Cured Orthodontic Band CementDYH · Traditional | 07/21/2000SE |
| K993324 | Carbocem Zinc Polycarboxylate CementEMA · Traditional | 11/09/1999SE |
| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | 12/17/1998SE |
| K982913 | Zinfos Zinc Phosphate CementEMA · Traditional | 10/19/1998SE |
| K944466 | SealdentEBI · Traditional | 03/02/1995SE |
Questions and answers
When was Propol Dental Polishing Paste cleared by the FDA?
Propol Dental Polishing Paste (K852489) received a 510(k) decision of Substantially Equivalent on July 1, 1985, 24 days after the submission was received.
What is the product code of K852489?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.