ENDEX BROACH, ENDODONTIC
FDA 510(k) clearance K800292 · decided 1980-02-19
Clearance details
- K-number
- K800292
- Device name
- ENDEX BROACH, ENDODONTIC
- Applicant
- Ipco Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-11
- Decision date
- 1980-02-19
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- EKW
- 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 |
|---|---|---|
| DENTI-TRAY(TM) (K871493) | Advanced Medical, Inc. | 1987-06-24 |
| CANNULATED INSTRUMENT CLEANERS (K870765) | Treace Medical, Inc. | 1987-05-27 |
| MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (K862523) | Walter Lorenz Surgical, Inc. | 1986-08-01 |
| ENDODONTIC BROACH(76EKN) BARBED BROACH (K831749) | Union Branch | 1983-07-12 |
| ENDODONTIC BROACH-BARBED BROACH (K823489) | Union Broach, Div. Moyco Industries, Inc. | 1982-12-15 |
| HAND INSTRUMENTS (K760985) | Adp Intl., Inc. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.