The following data is part of a premarket notification filed by 3m Unitek with the FDA for Tri-cure Glass Ionomer Orthodontic Band Cement.
| Device ID | K950514 |
| 510k Number | K950514 |
| Device Name: | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Contact | Marlyn Scheff |
| Correspondent | Marlyn Scheff 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00652221109040 | K950514 | 000 |
| 00652221109033 | K950514 | 000 |
| 00652221109026 | K950514 | 000 |