The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelperfect Conical Connection.
Device ID | K062936 |
510k Number | K062936 |
Device Name: | NOBELPERFECT CONICAL CONNECTION |
Classification | Implant, Endosseous, Root-form |
Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
Contact | Phuong Nguyen Son |
Correspondent | Phuong Nguyen Son NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-28 |
Decision Date | 2006-12-19 |
Summary: | summary |