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  |