DENPAX
FDA 510(k) clearance K860058 · decided 1986-03-12
Clearance details
- K-number
- K860058
- Device name
- DENPAX
- Applicant
- Nissho Iwai American Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-06
- Decision date
- 1986-03-12
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- EBR
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, 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 |
|---|---|---|
| A-DEC 7284 CUSPIDOR, CASCADE (K925367) | A-Dec, Inc. | 1994-04-11 |
| OROPHARYNGEAL SUCTION AIRWAY (K770600) | W.H. Wall, D.D.S. | 1977-04-08 |
Recalls involving this device
No recalls on record reference this clearance.