The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Spectra Form Chromatic Alginate Impression Material.
| Device ID | K980965 |
| 510k Number | K980965 |
| Device Name: | SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Contact | Bernard Van Dujin |
| Correspondent | Bernard Van Dujin CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-05-01 |