MICODOSE CHLORHEXIPREP
FDA 510(k) clearance K925163 · decided 1993-05-27
Clearance details
- K-number
- K925163
- Device name
- MICODOSE CHLORHEXIPREP
- Applicant
- Unicep
- Decision
- Substantially Equivalent
- Date received
- 1992-10-13
- Decision date
- 1993-05-27
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- ECM
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sandpoint, ID, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Unicep
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 |
|---|---|---|
| TITANE SL DENTAL BURR (K872471) | Titane SL Co. | 1987-09-11 |
Recalls involving this device
No recalls on record reference this clearance.