EJR — Agent, Polishing, Abrasive, Oral Cavity Class I
FDA Device Classification
Classification Details
- Product Code
- EJR
- Device Class
- Class I
- Regulation Number
- 872.6030
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K171189 | e.m.s electro medical systems | AIR-FLOW PLUS Prophylaxis powder | September 11, 2017 |
| K131760 | whip-mix | WHIP MIX PREPPIES PLUS | March 26, 2014 |
| K121698 | dentsply international | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | August 6, 2012 |
| K103114 | osspray | OSSPRAY SYLC CR | March 14, 2011 |
| K102053 | sunstar americas | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | February 3, 2011 |
| K101104 | voco | REMIN PRO | October 21, 2010 |
| K100539 | preventive technologies | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | June 17, 2010 |
| K070854 | gc america | GC MI PASTE PLUS | April 12, 2007 |
| K062502 | ospray | OSSPRAY CLEANING COMPOUND | December 15, 2006 |
| K062166 | premier dental products | ENAMEL PRO | November 21, 2006 |
| K042048 | deepak products | GELATO PROPHYLAXIS PASTE | October 26, 2004 |
| K042200 | gc america | MI PASTE | October 20, 2004 |
| K041371 | novamin technology | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | August 23, 2004 |
| K040988 | pascal co | ZIRCON-F PROPHYLAXIS PASTE | July 7, 2004 |
| K033785 | discus dental | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | June 18, 2004 |
| K040661 | pascal co | RADENT PROPHY PASTE | June 9, 2004 |
| K033449 | professional dental technologies therapeutics | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES | January 7, 2004 |
| K024343 | usbiomaterials | BUTLER GUM PROPHY PASTE WITH NOVAMIN | July 11, 2003 |
| K002989 | ortek therapeutics | PROCLUDE | December 14, 2000 |
| K000169 | dentsply intl | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | March 24, 2000 |