Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K211225 |
Device Name |
MIS Ti-base abutment |
Applicant |
Dentsply Sirona |
221 West Philadelphia Street, Suite 60W |
York,
PA
17401
|
|
Applicant Contact |
Rebecca Sporer |
Correspondent |
Dentsply Sirona |
221 West Philadelphia Street, Suite 60W |
York,
PA
17401
|
|
Correspondent Contact |
Rebecca Sporer |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 04/23/2021 |
Decision Date | 07/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|