FDA 510(k) Applications for Medical Device Product Code "EJR"
(Agent, Polishing, Abrasive, Oral Cavity)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K962370 | CHALLENGE PRODUCTS, INC. | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE | 03/31/1997 |
| K042048 | DEEPAK PRODUCTS, INC. | GELATO PROPHYLAXIS PASTE | 10/26/2004 |
| K121698 | DENTSPLY INTERNATIONAL INC. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 08/06/2012 |
| K983966 | DENTSPLY INTL. | NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN | 01/29/1999 |
| K000169 | DENTSPLY INTL. | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | 03/24/2000 |
| K033785 | DISCUS DENTAL, INC. | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | 06/18/2004 |
| K171189 | E.M.S. Electro Medical Systems S.A. | AIR-FLOW PLUS Prophylaxis powder | 09/11/2017 |
| K070854 | GC AMERICA, INC. | GC MI PASTE PLUS | 04/12/2007 |
| K042200 | GC AMERICA, INC. | MI PASTE | 10/20/2004 |
| K990482 | MINNESOTA MINING AND MFG. CO. | 3M CLINPRO PROPHY PASTE, MODEL 12611 | 05/13/1999 |
| K041371 | NOVAMIN TECHNOLOGY, INC. | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | 08/23/2004 |
| K002989 | ORTEK THERAPEUTICS, INC. | PROCLUDE | 12/14/2000 |
| K062502 | OSPRAY, LTD. | OSSPRAY CLEANING COMPOUND | 12/15/2006 |
| K103114 | OSSPRAY LTD | OSSPRAY SYLC CR | 03/14/2011 |
| K973289 | PACIFIC RIM DENTAL, INC. | RE NU | 02/09/1999 |
| K040661 | PASCAL CO., INC. | RADENT PROPHY PASTE | 06/09/2004 |
| K040988 | PASCAL CO., INC. | ZIRCON-F PROPHYLAXIS PASTE | 07/07/2004 |
| K062166 | PREMIER DENTAL PRODUCTS CO. | ENAMEL PRO | 11/21/2006 |
| K100539 | PREVENTIVE TECHNOLOGIES, INC. | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | 06/17/2010 |
| K033449 | PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES | 01/07/2004 |
| K102053 | SUNSTAR AMERICAS, INC. | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | 02/03/2011 |
| K024343 | USBIOMATERIALS CORP. | BUTLER GUM PROPHY PASTE WITH NOVAMIN | 07/11/2003 |
| K101104 | VOCO GMBH | REMIN PRO | 10/21/2010 |
| K131760 | WHIP-MIX CORP. | WHIP MIX PREPPIES PLUS | 03/26/2014 |
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