The following data is part of a premarket notification filed by Alexotek Co. with the FDA for Miniline Bracket.
| Device ID | K881789 |
| 510k Number | K881789 |
| Device Name: | MINILINE BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ALEXOTEK CO. 2440 WILLAMETTE ST. Eugene, OR 97405 |
| Contact | Wildman, Dds |
| Correspondent | Wildman, Dds ALEXOTEK CO. 2440 WILLAMETTE ST. Eugene, OR 97405 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-26 |
| Decision Date | 1988-06-01 |