The following data is part of a premarket notification filed by Curasan Ag with the FDA for Revois Implant System.
Device ID | K063106 |
510k Number | K063106 |
Device Name: | REVOIS IMPLANT SYSTEM |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
Contact | Eric Weichert |
Correspondent | Eric Weichert CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-11 |
Decision Date | 2007-06-11 |
Summary: | summary |