SOLVENEX I-0
FDA 510(k) clearance K771974 · decided 1978-01-12
Clearance details
- K-number
- K771974
- Device name
- SOLVENEX I-0
- Applicant
- Den-Mat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-17
- Decision date
- 1978-01-12
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KZP
- Device class
- 2
- Regulation number
- 872.3750
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Den-Mat Corp.
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 |
|---|---|---|
| TOOTH CONDITIONER (K920843) | Confi-Dental Products Co. | 1993-04-08 |
Recalls involving this device
No recalls on record reference this clearance.