Product code EJR
- Device name
- Agent, Polishing, Abrasive, Oral Cavity
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6030
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017-09-11 |
| K131760 | WHIP MIX PREPPIES PLUS | Whip-Mix Corp. | 2014-03-26 |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | 2012-08-06 |
| K103114 | OSSPRAY SYLC CR | Osspray, Ltd. | 2011-03-14 |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | 2011-02-03 |
| K101104 | REMIN PRO | Voco GmbH | 2010-10-21 |
| K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | Preventive Technologies, Inc. | 2010-06-17 |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | 2007-04-12 |
| K062502 | OSSPRAY CLEANING COMPOUND | Ospray, Ltd. | 2006-12-15 |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | 2006-11-21 |
| K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | 2004-10-26 |
| K042200 | MI PASTE | GC America, Inc. | 2004-10-20 |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | Novamin Technology, Inc. | 2004-08-23 |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Pascal Co., Inc. | 2004-07-07 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | 2004-06-18 |
| K040661 | RADENT PROPHY PASTE | Pascal Co., Inc. | 2004-06-09 |
| K033449 | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES | Professional Dental Technologies Therapeutics, Inc. | 2004-01-07 |
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Usbiomaterials Corp. | 2003-07-11 |
| K002989 | PROCLUDE | Ortek Therapeutics, Inc. | 2000-12-14 |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | 2000-03-24 |
| K990482 | 3M CLINPRO PROPHY PASTE, MODEL 12611 | Minnesota Mining and Mfg. Co. | 1999-05-13 |
| K973289 | RE NU | Pacific Rim Dental, Inc. | 1999-02-09 |
| K983966 | NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN | Dentsply Intl. | 1999-01-29 |
| K962370 | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE | Challenge Products, Inc. | 1997-03-31 |
| K944575 | AQUAFRESH PLAQUE FIGHTING GUM | Smithkline Beecham Consumer Healthcare Products | 1994-12-15 |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | Germiphene Corp. | 1994-11-04 |
| K940496 | PROPHY PASTE | Challenge Products, Inc. | 1994-04-19 |
| K935925 | VISION PROPHY PASTE WITH FLUORIDE | Block Drug Company, Inc. | 1994-01-26 |
| K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE | Block Drug Company, Inc. | 1993-11-16 |
| K923675 | DENSPRO MEDIUM MINT PROPHY PASTE | Teledyne Getz | 1992-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| EMICESA01 | Ena Shiny | MICERIUM SPA | 2025-11-07 |
| 07615208479232 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208480054 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479379 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479249 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479225 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479218 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479201 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208479195 | VivaDent Polishing Paste | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-12 |
| 07615208315615 | Proxyt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-07-14 |
| 07615208315608 | Proxyt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-07-14 |
| 07615208315592 | Proxyt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-07-14 |
| 07615208315585 | Proxyt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-07-14 |
| H66818208111 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208101 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208091 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208081 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208071 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208061 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208051 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208041 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208031 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208021 | Pure Life | Keystone Industries | 2022-11-30 |
| H66818208011 | Pure Life | Keystone Industries | 2022-11-30 |
| H668166961 | BOSWORTH | Keystone Industries | 2022-11-30 |
| H668166361 | BOSWORTH | Keystone Industries | 2022-11-30 |
| EMICESG71 | Ena Shiny | MICERIUM SPA | 2021-02-12 |
| H65810078691 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-16 |
| H65810477630 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |