Device Classification Name |
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
|
510(k) Number |
K122065 |
Device Name |
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE |
Applicant |
ORMCO CORP. |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Applicant Contact |
Wendy Garman |
Correspondent |
ORMCO CORP. |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Correspondent Contact |
Wendy Garman |
Regulation Number | 872.3661
|
Classification Product Code |
|
Date Received | 07/13/2012 |
Decision Date | 02/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|