Device Classification Name |
aligner, sequential
|
510(k) Number |
K200214 |
Device Name |
3D Predict |
Applicant |
3D Smile USA, Inc |
3675 Market Street Suite #200 |
philadelphia,
PA
19104
|
|
Applicant Contact |
marina domracheva |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
prithul bom |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 01/28/2020 |
Decision Date | 02/24/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|