MINIDENTOFLEX NEW POLISHING SYSTEM
FDA 510(k) clearance K780376 · decided 1978-03-14
Clearance details
- K-number
- K780376
- Device name
- MINIDENTOFLEX NEW POLISHING SYSTEM
- Applicant
- Cavitron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-08
- Decision date
- 1978-03-14
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- EHL
- 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 |
|---|---|---|
| CUTTER POINTS (K792250) | Cutter Laboratories, Inc. | 1980-01-23 |
| DENTAL ABRASIVE DEVICE (K780811) | Cavitron Corp. | 1978-06-22 |
| PINIDENTOFLEX DENTAL POLISHER (K780377) | Cavitron Corp. | 1978-03-14 |
Recalls involving this device
No recalls on record reference this clearance.