The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Ankylos C/x Implant System.
| Device ID | K140347 |
| 510k Number | K140347 |
| Device Name: | ANKYLOS C/X IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTSPLY INTL., INC. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL., INC. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-11 |
| Decision Date | 2014-08-20 |
| Summary: | summary |