The following data is part of a premarket notification filed by Rmo, Inc. with the FDA for Biolastic Super Elastic Arches.
| Device ID | K902050 |
| 510k Number | K902050 |
| Device Name: | BIOLASTIC SUPER ELASTIC ARCHES |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | RMO, INC. POST OFFICE BOX 17085 Denver, CO 80217 |
| Contact | Darrell D Parker |
| Correspondent | Darrell D Parker RMO, INC. POST OFFICE BOX 17085 Denver, CO 80217 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-07 |
| Decision Date | 1990-08-03 |