The following data is part of a premarket notification filed by Vident with the FDA for Vita In-ceram 2000 Al Cubes For Inlab, Models Al20/al40.
Device ID | K052130 |
510k Number | K052130 |
Device Name: | VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 |
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 | 2005-08-05 |
Decision Date | 2005-08-15 |