The following data is part of a premarket notification filed by Ortho Source with the FDA for Dependabond.
Device ID | K860959 |
510k Number | K860959 |
Device Name: | DEPENDABOND |
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 | 1986-03-13 |
Decision Date | 1986-03-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D9115578610 | K860959 | 000 |
D9115578460 | K860959 | 000 |
D9115574420 | K860959 | 000 |