Device Classification Name |
Dental Stereotaxic Instrument
|
510(k) Number |
K210711 |
Device Name |
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 |
Applicant |
Neocis Inc. |
2800 Biscayne Blvd. Suite 600 |
Miami,
FL
33137
|
|
Applicant Contact |
Dayana Manganese |
Correspondent |
Neocis Inc. |
2800 Biscayne Blvd. Suite 600 |
Miami,
FL
33137
|
|
Correspondent Contact |
William Tapia |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 03/10/2021 |
Decision Date | 12/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|