Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K160784 |
Device Name |
CAM Titanium Blanks |
Applicant |
ALTATEC GMBH |
MAYBACHSTRASSE 5 |
WIMSHEIM,
DE
D-71299
|
|
Applicant Contact |
COLLEEN BOSWELL |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL, SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA K. SCHULZ |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/22/2016 |
Decision Date | 09/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|