Neocis Guidance System— 510(k) K161399

Substantially Equivalent

Neocis, Inc.

FDA 510(k) clearance K161399 for Neocis Guidance System, Substantially Equivalent on 2016-12-22. Applicant: Neocis, Inc.. Device class: 2.

Clearance details

Applicant: Neocis, Inc.
Product code: Code PLV
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2016-05-20
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Neocis, Inc.

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Recalls naming K161399

K-number listed on FDA's recall record

Z-0511-2020 — Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.Class II·Terminated·Neocis Inc.·20191004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161399.

Data sourced from openFDA. This site is unofficial and independent of the FDA.