The following data is part of a premarket notification filed by Dentalpoint Ag with the FDA for Zeramex T And Zeramex Plus Dental Implant Systems.
| Device ID | K133255 |
| 510k Number | K133255 |
| Device Name: | ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTALPOINT AG 4 INNOVATION DRIVE Dundas, On, CA L9h 7p3 |
| Contact | Roshana Ahmed |
| Correspondent | Roshana Ahmed DENTALPOINT AG 4 INNOVATION DRIVE Dundas, On, CA L9h 7p3 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-23 |
| Decision Date | 2014-08-12 |
| Summary: | summary |