The following data is part of a premarket notification filed by Vident with the FDA for Scan White 12 Ml.
Device ID | K955406 |
510k Number | K955406 |
Device Name: | SCAN WHITE 12 ML |
Classification | Material, Impression |
Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Contact | Rav E Morrow |
Correspondent | Rav E Morrow VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-27 |
Decision Date | 1995-12-28 |