The following data is part of a premarket notification filed by Ortho Source with the FDA for Orthojoin, Orthodontic Adhesive.
| Device ID | K861118 |
| 510k Number | K861118 |
| Device Name: | ORTHOJOIN, ORTHODONTIC ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Contact | Lloyd R Taylor |
| Correspondent | Lloyd R Taylor ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-25 |
| Decision Date | 1986-05-02 |