The following data is part of a premarket notification filed by Ortho Source with the FDA for Permaband (orthodontic Adhesive).
| Device ID | K861258 |
| 510k Number | K861258 |
| Device Name: | PERMABAND (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 | 1986-04-03 |
| Decision Date | 1986-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D9115574820 | K861258 | 000 |
| D9115574780 | K861258 | 000 |
| D9115574770 | K861258 | 000 |
| D9115576200 | K861258 | 000 |
| D9115576070 | K861258 | 000 |