The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Quadrant Unibond.
| Device ID | K983545 |
| 510k Number | K983545 |
| Device Name: | QUADRANT UNIBOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Contact | Bernard Van Duijin |
| Correspondent | Bernard Van Duijin CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1998-11-18 |