The following data is part of a premarket notification filed by Ortho Source with the FDA for Maxibond.
| Device ID | K884575 |
| 510k Number | K884575 |
| Device Name: | MAXIBOND |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Contact | Taylor, Dds |
| Correspondent | Taylor, Dds 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 | 1988-11-01 |
| Decision Date | 1989-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAXIBOND 88156128 not registered Live/Pending |
Cempro LLC 2018-10-16 |
![]() MAXIBOND 85730281 not registered Dead/Abandoned |
AMCOL International Corporation 2012-09-17 |