The following data is part of a premarket notification filed by American Orthodontics with the FDA for Bracepaste Mtp Light Cure Primer.
| Device ID | K181910 |
| 510k Number | K181910 |
| Device Name: | BracePaste MTP Light Cure Primer |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Contact | Trang Adams |
| Correspondent | Andre Leak American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2018-10-15 |
| Summary: | summary |