The following data is part of a premarket notification filed by American Orthodontics with the FDA for Bracepaste Adhesive.
| Device ID | K160782 |
| 510k Number | K160782 |
| Device Name: | BracePaste Adhesive |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Contact | Trang Adams |
| Correspondent | Trang Adams American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-22 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746034855 | K160782 | 000 |
| 00190746059322 | K160782 | 000 |
| 00190746059292 | K160782 | 000 |
| 00190746059285 | K160782 | 000 |
| 00190746059278 | K160782 | 000 |
| 00190746059261 | K160782 | 000 |
| 00190746059223 | K160782 | 000 |
| 00190746059216 | K160782 | 000 |
| 00190746059209 | K160782 | 000 |
| 00190746134395 | K160782 | 000 |
| 00190746134388 | K160782 | 000 |
| 00190746034848 | K160782 | 000 |
| 00190746034831 | K160782 | 000 |
| 00190746034824 | K160782 | 000 |
| 00190746134746 | K160782 | 000 |
| 00190746134739 | K160782 | 000 |
| 00190746150821 | K160782 | 000 |
| 00190746150814 | K160782 | 000 |
| 00190746150807 | K160782 | 000 |
| 00190746059193 | K160782 | 000 |