PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
FDA 510(k) clearance K781035 · decided 1978-06-30
Clearance details
- K-number
- K781035
- Device name
- PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-19
- Decision date
- 1978-06-30
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- EMN
- Device class
- 1
- Regulation number
- 872.4565
- 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 |
|---|---|---|
| PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127) | Kevin Vu, Dds | 2007-03-29 |
| DENTAL INSTRUMENTS SCALER (K931330) | Minnesota Prophy Power, Inc. | 1994-01-26 |
| 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (K851721) | Artiberia | 1985-07-02 |
| BEACH SCALERS (K821786) | Pacific Dental Corp. | 1982-07-06 |
Recalls involving this device
No recalls on record reference this clearance.