The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Everest G-blank, Kavo Everest G-ceram, Coating Ceramic Lf-3-pfm, Glaze And Colorings/staining/shades.
Device ID | K030607 |
510k Number | K030607 |
Device Name: | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES |
Classification | Powder, Porcelain |
Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Contact | Jennifer Pottala |
Correspondent | Jennifer Pottala KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-26 |
Decision Date | 2003-05-02 |
Summary: | summary |