The following data is part of a premarket notification filed by Rocky Mountain Orthodontics, Inc. with the FDA for Impression Tray.
| Device ID | K780678 |
| 510k Number | K780678 |
| Device Name: | IMPRESSION TRAY |
| Classification | Tray, Impression, Preformed |
| Applicant | ROCKY MOUNTAIN ORTHODONTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHY |
| CFR Regulation Number | 872.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-24 |
| Decision Date | 1978-04-28 |