The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Carrara Press System.
Device ID | K033667 |
510k Number | K033667 |
Device Name: | CARRARA PRESS SYSTEM |
Classification | Powder, Porcelain |
Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
Contact | P. Jeffery Lehn |
Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-21 |
Decision Date | 2004-01-23 |
Summary: | summary |