The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Acclaim* Bracket Adhesive.
| Device ID | K864008 |
| 510k Number | K864008 |
| Device Name: | ACCLAIM* 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 E Landsman |
| Correspondent | Carol E 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 | 1986-10-15 |
| Decision Date | 1986-10-24 |