The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Everest Zs-blank Models, 42, 20, And 60.
Device ID | K032081 |
510k Number | K032081 |
Device Name: | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 |
Classification | Powder, Porcelain |
Applicant | KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-07 |
Decision Date | 2003-07-24 |
Summary: | summary |