ELEVATOR - VARIOUS
FDA 510(k) clearance K841011 · decided 1984-06-15
Clearance details
- K-number
- K841011
- Device name
- ELEVATOR - VARIOUS
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-09
- Decision date
- 1984-06-15
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- EMS
- 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 |
|---|---|---|
| DENTAL INSTRUMENTS CURETTE PERIODONTAL (K931329) | Minnesota Prophy Power, Inc. | 1994-01-27 |
| CURRETTES, ALVEOLAR (MOLT AND MILLER) (K872091) | Military Engineering, Inc. | 1987-07-31 |
| CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (K870590) | Military Engineering, Inc. | 1987-04-16 |
| INSTRUMENT, DENTAL (K834072) | Venture Technology, Inc. | 1984-02-21 |
| DENTAL INSTRUMENTS - SCALERS (K823319) | Miltex, Inc. | 1982-11-24 |
| BEACH CURETTE NO. 2 AND NO. 3 T.G. (K821789) | Pacific Dental Corp. | 1982-07-06 |
Recalls involving this device
No recalls on record reference this clearance.