The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Zi Abutment.
Device ID | K091904 |
510k Number | K091904 |
Device Name: | NOBELPROCERA ZI ABUTMENT |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Herbert Crane |
Correspondent | Herbert Crane NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-25 |
Decision Date | 2009-09-25 |
Summary: | summary |