CP-3 Dental Polishing Material
FDA 510(k) K901973 · Gresco Products, Inc.
510(k) numberK901973
Submission
- Device name
- CP-3 Dental Polishing Material
- Applicant
- Gresco Products, Inc.
Stafford, TX, US - Received
- May 1, 1990
- Decision date
- June 1, 1990
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K981524 | PrilaneEIH · Traditional | 07/10/1998SE |
| K913405 | Kar-D-TekLFC · Traditional | 10/28/1991SE |
| K910813 | Met-EtchEBC · Traditional | 05/07/1991SE |
| K910803 | Enamel Etching GelDYH · Traditional | 03/15/1991SE |
| K854495 | Gresco N.P. Dental AlloyEJH · Traditional | 12/27/1985SE |
| K854494 | Ceram-EtchEBC · Traditional | 12/23/1985SE |
Questions and answers
When was CP-3 Dental Polishing Material cleared by the FDA?
CP-3 Dental Polishing Material (K901973) received a 510(k) decision of Substantially Equivalent on June 1, 1990, 31 days after the submission was received.
What is the product code of K901973?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.