K880393 is an FDA 510(k) clearance for the TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on March 31, 1988, 62 days after receiving the submission on January 29, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K880393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1988 |
| Decision Date | March 31, 1988 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |