The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Cavex Colorchange.
| Device ID | K011419 |
| 510k Number | K011419 |
| Device Name: | CAVEX COLORCHANGE |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman 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 | 2001-05-09 |
| Decision Date | 2001-07-16 |