PLUSTRON ION TOOTHBRUSH SYSTEM
FDA 510(k) clearance K971639 · decided 1997-06-24
Clearance details
- K-number
- K971639
- Device name
- PLUSTRON ION TOOTHBRUSH SYSTEM
- Applicant
- Sas Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-02
- Decision date
- 1997-06-24
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- MMD
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| HUBUKA HYG TOOTHBRUSH (K915576) | Hukuba Dental Corp. | 1994-03-04 |
Recalls involving this device
No recalls on record reference this clearance.