GROMAN PREPMASTER
FDA 510(k) clearance K030292 · decided 2003-04-15
Clearance details
- K-number
- K030292
- Device name
- GROMAN PREPMASTER
- Applicant
- Groman, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-28
- Decision date
- 2003-04-15
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KOJ
- Device class
- 2
- Regulation number
- 872.6080
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Margate, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| turbodent touch (K251425) | Mectron S.P.A. | 2025-05-09 |
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| PREPAIR (K033215) | Danville Materials, Inc. | 2004-01-09 |
| VELOPEX AQUACUT FLUID ABRASION UNIT (K024105) | Velopex International, Inc. | 2003-10-09 |
| 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.