The following data is part of a premarket notification filed by Vident with the FDA for Vita Vm7, Model Nx77 Xxxx, Nx78xxxx, Nx79 Xxxx; Vita Vm 8, Model Vx60 Xxxx, Vx61 Xxxx, Vx62 Xxxx; Vita Vm 9,.
Device ID | K052710 |
510k Number | K052710 |
Device Name: | VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, |
Classification | Powder, Porcelain |
Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Contact | Barbara J Lewandowski |
Correspondent | Barbara J Lewandowski VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-29 |
Decision Date | 2006-01-13 |
Summary: | summary |