BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
FDA 510(k) clearance K821788 · decided 1982-07-06
Clearance details
- K-number
- K821788
- Device name
- BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
- Applicant
- Pacific Dental Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-17
- Decision date
- 1982-07-06
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- EMJ
- 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 |
|---|---|---|
| ELEVATOR, ROOT, SINGLE-ENDED (K870589) | Military Engineering, Inc. | 1987-04-03 |
| 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR (K851717) | Artiberia | 1985-06-14 |
| 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA (K851713) | Artiberia | 1985-06-11 |
| TACTILE PLUS DENTAL ELEVATORS (K850906) | Ipco Corp. | 1985-04-12 |
| PERIOSTEAL ELEVATOR (K771747) | Depuy, Inc. | 1977-09-28 |
Recalls involving this device
No recalls on record reference this clearance.