FLOWABLE HYBRID
FDA 510(k) clearance K980298 · decided 1998-03-09
Clearance details
- K-number
- K980298
- Device name
- FLOWABLE HYBRID
- Applicant
- Cosmedent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-27
- Decision date
- 1998-03-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- EBD
- Device class
- 2
- Regulation number
- 872.3310
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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| EASY GLAZE (K082285) | Voco GmbH | 2008-10-24 |
| DURAFINISH ALL-CURE, MODEL S296 (K080549) | Parkell, Inc. | 2008-05-13 |
Recalls involving this device
No recalls on record reference this clearance.