Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K181520 |
Device Name |
Sirona Dental CAD/CAM System |
Applicant |
Dentsply Sirona |
221 West Philadelphia St., Suite 60W |
York,
PA
17401
|
|
Applicant Contact |
Karl J. Nittinger |
Correspondent |
Dentsply Sirona |
221 West Philadelphia St., Suite 60W |
York,
PA
17401
|
|
Correspondent Contact |
Karl J. Nittinger |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2018 |
Decision Date | 10/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|