The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Orion-1 Vl Crown Base And Post Cement Visible Light Cure.
| Device ID | K960597 |
| 510k Number | K960597 |
| Device Name: | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana, CA 91356 |
| Contact | Eugene Zarotsky |
| Correspondent | Eugene Zarotsky DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana, CA 91356 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-04-26 |