The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Ducera Allceram.
Device ID | K043247 |
510k Number | K043247 |
Device Name: | DUCERA ALLCERAM |
Classification | Powder, Porcelain |
Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
Contact | Helen Lewis |
Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-23 |
Decision Date | 2004-12-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DUCERA ALLCERAM 76033505 2987663 Dead/Cancelled |
DEGUDENT GMBH 2000-04-25 |