The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Friadent Cercon And Ankylos Cercon Balance Abutments.
Device ID | K072730 |
510k Number | K072730 |
Device Name: | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
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 | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-26 |
Decision Date | 2008-03-27 |
Summary: | summary |