BETA-POWDER
FDA 510(k) clearance K063236 · decided 2007-02-16
Clearance details
- K-number
- K063236
- Device name
- BETA-POWDER
- Applicant
- Brainbase Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-10-25
- Decision date
- 2007-02-16
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- KOJ
- Device class
- 2
- Regulation number
- 872.6080
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Shinagawa-Ku Tokyo, JP
- 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 |
|---|---|---|
| turbodent touch (K251425) | Mectron S.P.A. | 2025-05-09 |
| RONDOFLEX PLUS 360 (K042872) | Kavo America Corporation | 2004-11-23 |
| PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (K033675) | Sirona Dental Systems GmbH | 2004-01-15 |
| PREPAIR (K033215) | Danville Materials, Inc. | 2004-01-09 |
| VELOPEX AQUACUT FLUID ABRASION UNIT (K024105) | Velopex International, Inc. | 2003-10-09 |
| GROMAN PREPMASTER (K030292) | Groman, Inc. | 2003-04-15 |
| CLINPRO PROPHY POWDER (K021450) | 3M Espe AG Dental Products | 2002-08-01 |
| NEW PROPHY POWDER (K014188) | Dentsply Intl. | 2002-03-15 |
| JETPOLISHER (K014249) | Deldent , Ltd. | 2002-02-19 |
| JETSTREAM (K014252) | Deldent , Ltd. | 2002-02-19 |
| JETSONIC 2000 (K014245) | Deldent , Ltd. | 2002-01-29 |
| MINIBLASTER (K013969) | Deldent , Ltd. | 2002-01-10 |
Recalls involving this device
No recalls on record reference this clearance.