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 |