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FDA 510(k) Application Details - K210711
Device Classification Name
More FDA Info for this Device
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 US
Other 510(k) Applications for this Company
Contact
Dayana Manganese
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2021
Decision Date
12/22/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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