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FDA 510(k)

Neocis Guidance System (NGS) with Intraoral Fiducial Array

K-Number: K211129 · 2021-07-28

ApplicantNeocis, Inc.
Decision Date2021-07-28
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Intraoral Fiducial Array is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211129. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neocis Guidance System (NGS) with Intraoral Fiducial Array?

Neocis Guidance System (NGS) with Intraoral Fiducial Array is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Neocis, Inc.. The 510(k) number is K211129.

When was Neocis Guidance System (NGS) with Intraoral Fiducial Array approved by the FDA?

Neocis Guidance System (NGS) with Intraoral Fiducial Array received FDA 510(k) clearance on 2021-07-28, under approval number K211129.

What company makes Neocis Guidance System (NGS) with Intraoral Fiducial Array?

Neocis Guidance System (NGS) with Intraoral Fiducial Array is manufactured by Neocis, Inc..

What is the FDA product code for Neocis Guidance System (NGS) with Intraoral Fiducial Array?

The FDA product code for Neocis Guidance System (NGS) with Intraoral Fiducial Array is PLV.

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Other Devices by Neocis, Inc.

K161399Neocis Guidance System K182776Neocis Guidance System K173402Neocis Guidance System (NGS) with Chairside Splint K191363Neocis Planning Software Application (NPSA) for 3rd Party PCs K191605Neocis Guidance System (NGS) K203401Neocis Guidance System (NGS) with Patient Splints (EPS)

View all 18 devices →

Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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