Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K183542 |
Device Name |
Signature Orthodontic System |
Applicant |
Signature Orthodontics |
1035 Cambridge Street, Suite 14a |
Cambridge,
MA
02141
|
|
Applicant Contact |
Alfred Charles Griffin |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 12/20/2018 |
Decision Date | 01/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|