The following data is part of a premarket notification filed by Rocky Mountain Orthodontics, Inc. with the FDA for Orthodontic Buccal Tube.
| Device ID | K780205 |
| 510k Number | K780205 |
| Device Name: | ORTHODONTIC BUCCAL TUBE |
| Classification | Tube, Orthodontic |
| Applicant | ROCKY MOUNTAIN ORTHODONTICS, INC. 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 | 1978-02-07 |
| Decision Date | 1978-02-16 |