SMYLON (DENTAL STAIN ERASER)
FDA 510(k) clearance K891338 · decided 1989-11-14
Clearance details
- K-number
- K891338
- Device name
- SMYLON (DENTAL STAIN ERASER)
- Applicant
- The Smylon Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-13
- Decision date
- 1989-11-14
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- MAU
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Los Angeles, CA, 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 |
|---|---|---|
| CLINI-DENT (K000140) | The Precident Group | 2000-05-03 |
Recalls involving this device
No recalls on record reference this clearance.