The following data is part of a premarket notification filed by Nobel Biocare Usa Llc with the FDA for Nobelprocera Zi Abutment Thommen Platforms.
Device ID | K110171 |
510k Number | K110171 |
Device Name: | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
Contact | Herbert Crane |
Correspondent | Herbert Crane NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-20 |
Decision Date | 2011-06-15 |
Summary: | summary |