The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Zarolan, Dualan, Titan And Superon.
| Device ID | K891698 |
| 510k Number | K891698 |
| Device Name: | ZAROLAN, DUALAN, TITAN AND SUPERON |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles, CA 90069 |
| Contact | David Zarotsky |
| Correspondent | David Zarotsky DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles, CA 90069 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-06-09 |