FDA · official record K202264Substantially Equivalent

Neocis Guidance System (NGS) with Yomi Plan v2.0

Name: Neocis Guidance System (NGS) with Yomi Plan v2.0 — FDA K202264
Creator: Neocis, Inc.
Keywords: Neocis Guidance System (NGS) with Yomi Plan v2.0, Neocis Guidance System (NGS) with Yomi Plan v2.0, K202264, PLV, FDA

United StatesPLVNeocis, Inc.

Verified

Official record identity

FDA application number: K202264
Decision date: December 04, 2020
Published decision: Substantially Equivalent

Classification

Product code: PLV

Published parties

Applicant: Neocis, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-08-11
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4120

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.