FDA · official record K192015Substantially Equivalent

Faico Dental Implant System

Name: Faico Dental Implant System — FDA K192015
Creator: Faico Medical, LLC
Keywords: Faico Dental Implant System, Faico Dental Implant System, K192015, DZE, FDA

United StatesDZEFaico Medical, LLC

Verified

Official record identity

FDA application number: K192015
Decision date: April 03, 2020
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Faico Medical, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-07-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.