The following data is part of a premarket notification filed by Rocky Mountain Orthodontics, Inc. with the FDA for Orthomite 111 Adhesive.
| Device ID | K843527 |
| 510k Number | K843527 |
| Device Name: | ORTHOMITE 111 ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | ROCKY MOUNTAIN ORTHODONTICS, INC. P.O. BOX 17085 Denver, CO 80217 |
| Contact | Kevin R Cook |
| Correspondent | Kevin R Cook ROCKY MOUNTAIN ORTHODONTICS, INC. P.O. BOX 17085 Denver, CO 80217 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-10-18 |