The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Cavex Temporary Cement.
| Device ID | K003791 |
| 510k Number | K003791 |
| Device Name: | CAVEX TEMPORARY CEMENT |
| Classification | Cement, Dental |
| Applicant | CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman CAVEX HOLLAND B.V. 2003 RW HAARLEM PO BOX 852 Harmen, NL 19-21 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E241CE0900 | K003791 | 000 |