Device Classification Name |
orthodontic software
|
510(k) Number |
K193003 |
Device Name |
NemoCast |
Applicant |
Software Nemotec S.L. |
Juan de la Cierva Street, 66 |
Arroyomolinos, Madrid,
ES
28939
|
|
Applicant Contact |
Carlos Arias |
Correspondent |
Regulatory Insight, Inc. |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 872.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/2019 |
Decision Date | 06/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|