Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K212664 |
Device Name |
Sherlock |
Applicant |
Open Implants, LLC |
800 West Cummngs Ave, Suite 4900 |
Woburn,
MA
01801
|
|
Applicant Contact |
Gregg Gellman |
Correspondent |
Aclivi, LLC |
3250 Brackley Drive |
Ann Arbor,
MI
48105
|
|
Correspondent Contact |
Chris Brown |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 08/23/2021 |
Decision Date | 11/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|