The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Excel Bracket Adhesive.
| Device ID | K854050 |
| 510k Number | K854050 |
| Device Name: | EXCEL BRACKET ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Contact | Carol Landsman |
| Correspondent | Carol Landsman JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-03 |
| Decision Date | 1985-11-26 |