The following data is part of a premarket notification filed by American Orthodontics with the FDA for Bandtite Glass Ionomer Cement.
| Device ID | K896249 |
| 510k Number | K896249 |
| Device Name: | BANDTITE GLASS IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Contact | Paul Riddle |
| Correspondent | Paul Riddle AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. Sheboygan, WI 53081 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746157141 | K896249 | 000 |
| 00190746157134 | K896249 | 000 |
| 00190746059346 | K896249 | 000 |
| 00190746059339 | K896249 | 000 |