The following data is part of a premarket notification filed by Neodent Usa, Inc. with the FDA for Neodent Implant System, Titamax Ti Ex Acqua And Ti Drive Acqua, Titamax Smart Ex Acqua And Drive Smart Acqua, Titamax Cm.
| Device ID | K133592 |
| 510k Number | K133592 |
| Device Name: | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEODENT USA, INC. 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk NEODENT USA, INC. 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-22 |
| Decision Date | 2014-08-22 |
| Summary: | summary |