HUBUKA HYG TOOTHBRUSH
FDA 510(k) clearance K915576 · decided 1994-03-04
Clearance details
- K-number
- K915576
- Device name
- HUBUKA HYG TOOTHBRUSH
- Applicant
- Hukuba Dental Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-12
- Decision date
- 1994-03-04
- Days to decision
- 813 days
- Clearance type
- Traditional
- Product code
- MMD
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Nagareyama City, Chiba, 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 |
|---|---|---|
| PLUSTRON ION TOOTHBRUSH SYSTEM (K971639) | Sas Group, Inc. | 1997-06-24 |
Recalls involving this device
No recalls on record reference this clearance.