The following data is part of a premarket notification filed by Rocky Mountain Orthodontics, Inc. with the FDA for Northernlights Orthodontic Bonding System.
| Device ID | K895401 |
| 510k Number | K895401 |
| Device Name: | NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ROCKY MOUNTAIN ORTHODONTICS, INC. P.O. BOX 17085 Denver, CO 80217 |
| Contact | Darrell Parker |
| Correspondent | Darrell Parker ROCKY MOUNTAIN ORTHODONTICS, INC. P.O. BOX 17085 Denver, CO 80217 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-07 |
| Decision Date | 1989-12-04 |