Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K974150 |
Device Name |
PROCERA PREPARABLE ABUTMENT SYSTEM |
Applicant |
NOBEL BIOCARE UAS INC |
777 OAKMONT LANE, SUITE 100 |
WESTMONT,
IL
60559
|
|
Applicant Contact |
BETSY A BROWN |
Correspondent |
NOBEL BIOCARE UAS INC |
777 OAKMONT LANE, SUITE 100 |
WESTMONT,
IL
60559
|
|
Correspondent Contact |
BETSY A BROWN |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/04/1997 |
Decision Date | 01/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|