ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
FDA 510(k) clearance K901994 · decided 1990-07-31
Clearance details
- K-number
- K901994
- Device name
- ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
- Applicant
- Rosofsky & Ross, Inc.
- Decision
- Unknown
- Date received
- 1990-05-02
- Decision date
- 1990-07-31
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EFW
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DENTEK EASY BRUSH WITH FLUORIDE (K130186) | Den Tek Oral Care, Inc. | 2013-07-15 |
| BEAM BRUSH/BEAM APP (K121165) | Beam Technologies, LLC | 2012-06-21 |
| SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871) | Piave Spazzolificio S.P.A. | 2011-10-03 |
| ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224) | Procter & Gamble | 2008-02-06 |
| ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (K021383) | Agion Technologies, LLC | 2002-07-17 |
| MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (K020776) | Coronet Group North America, LLC | 2002-06-03 |
| LAZERSMILE, LAZERWHITE (K000290) | Biolase Technology, Inc. | 2000-04-14 |
| TOOTHBRUSH WASH (K994144) | Cal Huech, Inc. | 2000-03-02 |
| BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (K992435) | Azo Enterprises | 1999-10-15 |
| PLAQ-ATAQ-I (K980995) | Ethicare | 1998-08-20 |
| BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761) | John O. Butler Co. | 1998-06-16 |
| CREST TOOTHBRUSH WITH MICROSHIELD (K973236) | Procter & Gamble Co. | 1998-03-11 |
Recalls involving this device
No recalls on record reference this clearance.