ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
FDA 510(k) clearance K935443 · decided 1994-09-20
Clearance details
- K-number
- K935443
- Device name
- ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
- Applicant
- Osada Electric Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-12
- Decision date
- 1994-09-20
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- DZH
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Los Angeles, CA, 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 |
|---|---|---|
| DENTATUS OSCIOMAT (K031793) | Dentatus USA , Ltd. | 2003-11-13 |
| SURGICAL OSCILLATING SAW (K760958) | American Safety Equipment Corp. | 1976-11-16 |
| SURGICAL RECIPROCATING SAW (K760957) | American Safety Equipment Corp. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.