The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236.
Device ID | K040573 |
510k Number | K040573 |
Device Name: | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Elizabeth J Mason |
Correspondent | Elizabeth J Mason NOBEL BIOCARE UAS INC 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 | 2004-03-04 |
Decision Date | 2004-04-28 |
Summary: | summary |