The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Tulip Alginate Impression Material.
| Device ID | K023466 |
| 510k Number | K023466 |
| Device Name: | TULIP ALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. PO BOX 852 Haarlem (holland), NL 2003 Rw |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman CAVEX HOLLAND B.V. PO BOX 852 Haarlem (holland), NL 2003 Rw |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-16 |
| Decision Date | 2002-12-13 |