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FDA 510(k)

Faico Dental Implant System

K-Number: K192015 · 2020-04-03

ApplicantFaico Medical, LLC
Decision Date2020-04-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Faico Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Faico Medical, LLC. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K192015. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Faico Dental Implant System?

Faico Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is Faico Medical, LLC. The 510(k) number is K192015.

When did Faico Dental Implant System receive FDA 510(k) clearance?

Faico Dental Implant System received FDA 510(k) clearance on 2020-04-03, under 510(k) number K192015.

Who is the listed applicant for Faico Dental Implant System?

The FDA 510(k) record lists Faico Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Faico Dental Implant System?

The FDA product code for Faico Dental Implant System is DZE.

Other records listing Faico Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211871FAICO Dental Implant System and CAD/CAM AbutmentsK191997FAICO CMF System

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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