The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Gluflorma.
| Device ID | K955740 |
| 510k Number | K955740 |
| Device Name: | GLUFLORMA |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Contact | Jeffery L Fasnacht |
| Correspondent | Jeffery L Fasnacht MIDWEST ORTHODONTIC MFG. 4570 PROGRESS DR. Columbus, IN 47201 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-02-08 |