The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Algetral, Cavex Chromatic, Ca 37 Superior Pink, Ca 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi.
| Device ID | K981970 |
| 510k Number | K981970 |
| Device Name: | ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Contact | Bernard Van Duijn |
| Correspondent | Bernard Van Duijn CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1998-09-02 |