EJR · Agent, Polishing, Abrasive, Oral Cavity
Dental · 21 CFR 872.6030 · Class 1
Overview
| Product Code | EJR |
|---|---|
| Device Name | Agent, Polishing, Abrasive, Oral Cavity |
| Regulation | 21 CFR 872.6030 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | Sep 11, 2017 | SESE |
| K131760 | WHIP MIX PREPPIES PLUS | Whip-Mix Corp. | Mar 26, 2014 | SESE |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | Aug 6, 2012 | SESE |
| K103114 | OSSPRAY SYLC CR | Osspray, Ltd. | Mar 14, 2011 | SESE |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | Feb 3, 2011 | SESE |
| K101104 | REMIN PRO | Voco GmbH | Oct 21, 2010 | SESE |
| K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | Preventive Technologies, Inc. | Jun 17, 2010 | SESE |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | Apr 12, 2007 | SESE |
| K062502 | OSSPRAY CLEANING COMPOUND | Ospray, Ltd. | Dec 15, 2006 | SESE |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | Nov 21, 2006 | SESE |
| K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | Oct 26, 2004 | SESE |
| K042200 | MI PASTE | GC America, Inc. | Oct 20, 2004 | SESE |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | Novamin Technology, Inc. | Aug 23, 2004 | SESE |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Pascal Co., Inc. | Jul 7, 2004 | SESE |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | Jun 18, 2004 | SESE |
| K040661 | RADENT PROPHY PASTE | Pascal Co., Inc. | Jun 9, 2004 | SESE |
| K033449 | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES | Professional Dental Technologies Therapeutics, Inc. | Jan 7, 2004 | SESE |
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Usbiomaterials Corp. | Jul 11, 2003 | SESE |
| K002989 | PROCLUDE | Ortek Therapeutics, Inc. | Dec 14, 2000 | SESE |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | Mar 24, 2000 | SESE |
Top Applicants
- Scientific Pharmaceuticals, Inc. — 7 clearances
- Dentsply Intl. — 5 clearances
- Imd, Inc. — 3 clearances
- Pulpdent Corp. — 3 clearances
- Antraco, Inc. — 2 clearances
