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FDA 510(k)

Implacil Implant System

K-Number: K202832 · 2021-05-26

ApplicantImplacil DE Bortoli Material Odontologico Ltda
Decision Date2021-05-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implacil Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Implacil DE Bortoli Material Odontologico Ltda. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K202832. 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 Implacil Implant System?

Implacil Implant System is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Implacil DE Bortoli Material Odontologico Ltda. The 510(k) number is K202832.

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

Implacil Implant System received FDA 510(k) clearance on 2021-05-26, under 510(k) number K202832.

Who is the listed applicant for Implacil Implant System?

The FDA 510(k) record lists Implacil DE Bortoli Material Odontologico Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implacil Implant System?

The FDA product code for Implacil Implant System is DZE.

Other records listing Implacil DE Bortoli Material Odontologico Ltda 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.

K183024Implacil Implant 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

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

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