DENTATUS OSCIOMAT
FDA 510(k) clearance K031793 · decided 2003-11-13
Clearance details
- K-number
- K031793
- Device name
- DENTATUS OSCIOMAT
- Applicant
- Dentatus USA , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-10
- Decision date
- 2003-11-13
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- DZH
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sound Beach, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dentatus USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (K935443) | Osada Electric Co., Ltd. | 1994-09-20 |
| 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.