The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Quadrant Total Etch.
| Device ID | K984043 |
| 510k Number | K984043 |
| Device Name: | QUADRANT TOTAL ETCH |
| Classification | Material, Tooth Shade, Resin |
| Applicant | CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Contact | Bernard Van Duijn |
| Correspondent | Bernard Van Duijn CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1998-12-04 |