K940165 is an FDA 510(k) clearance for the ALASTIK. This device is classified as a Band, Elastic, Orthodontic (Class I - General Controls, product code ECI).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on March 7, 1994, 60 days after receiving the submission on January 6, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K940165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1994 |
| Decision Date | March 07, 1994 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ECI — Band, Elastic, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |