The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Tiadapt Abutment System.
Device ID | K971706 |
510k Number | K971706 |
Device Name: | TIADAPT ABUTMENT SYSTEM |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
Contact | Betsy A Brown |
Correspondent | Betsy A Brown NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-08 |
Decision Date | 1997-07-21 |
Summary: | summary |