PROFLEX FLEXIBLE SCALER
FDA 510(k) clearance K821364 · decided 1982-05-28
Clearance details
- K-number
- K821364
- Device name
- PROFLEX FLEXIBLE SCALER
- Applicant
- Teledyne Densco
- Decision
- Substantially Equivalent
- Date received
- 1982-05-07
- Decision date
- 1982-05-28
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- EHM
- Device class
- 1
- Regulation number
- 872.6010
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| RUWA FINISHING STRIPS (K790598) | Howmedica Corp. | 1979-05-21 |
Recalls involving this device
No recalls on record reference this clearance.