The following data is part of a premarket notification filed by Alexotek Co. with the FDA for Labial Cuspid Tube.
| Device ID | K834392 |
| 510k Number | K834392 |
| Device Name: | LABIAL CUSPID TUBE |
| Classification | Tube, Orthodontic |
| Applicant | ALEXOTEK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZD |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-28 |