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FDA 510(k)

SGS Dental Implants System

K-Number: K182219 · 2019-08-29

ApplicantSgs International, Ltd.
Decision Date2019-08-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SGS Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Sgs International, Ltd.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K182219. 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 SGS Dental Implants System?

SGS Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Sgs International, Ltd.. The 510(k) number is K182219.

When did SGS Dental Implants System receive FDA 510(k) clearance?

SGS Dental Implants System received FDA 510(k) clearance on 2019-08-29, under 510(k) number K182219.

Who is the listed applicant for SGS Dental Implants System?

The FDA 510(k) record lists Sgs International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SGS Dental Implants System?

The FDA product code for SGS Dental Implants System is DZE.

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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