WILEY/ESPOSITO DENTAL GUARD
FDA 510(k) clearance K935713 · decided 1994-01-05
Clearance details
- K-number
- K935713
- Device name
- WILEY/ESPOSITO DENTAL GUARD
- Applicant
- Fvtnks
- Decision
- Substantially Equivalent
- Date received
- 1993-11-30
- Decision date
- 1994-01-05
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- BRW
- Device class
- 1
- Regulation number
- 868.5820
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fvtnks
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 |
|---|---|---|
| CATCO NEONATAL PALATE GUARD (K945727) | Catco Medical, Inc. | 1994-12-07 |
| TIP TOLEDO INCISOR PROTECTOR (K851640) | Edward O. Goodwich | 1985-09-18 |
Recalls involving this device
No recalls on record reference this clearance.