K881789 is an FDA 510(k) clearance for the MINILINE BRACKET. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).
Submitted by Alexotek Co. (Eugene, US). The FDA issued a Cleared decision on June 1, 1988, 36 days after receiving the submission on April 26, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K881789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1988 |
| Decision Date | June 01, 1988 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJF — Bracket, Metal, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |