The following data is part of a premarket notification filed by Ortho Source with the FDA for Visible Light Cure Calcium Hydroxide Liner.
| Device ID | K884949 |
| 510k Number | K884949 |
| Device Name: | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER |
| Classification | Liner, Cavity, Calcium Hydroxide |
| 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 | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-25 |
| Decision Date | 1989-02-23 |