The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Quadrant Unichem.
| Device ID | K983751 |
| 510k Number | K983751 |
| Device Name: | QUADRANT UNICHEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | CAVEX HOLLAND B.V. HARMENJANSWEG 21 Haarlem, NL 2031 Wh |
| Contact | Bernard Van Duijn |
| Correspondent | Bernard Van Duijn CAVEX HOLLAND B.V. HARMENJANSWEG 21 Haarlem, NL 2031 Wh |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-23 |
| Decision Date | 1998-11-30 |