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FDA 510(k)

EM SA Implant System

K-Number: K191201 · 2019-11-15

ApplicantHiossen, Inc.
Decision Date2019-11-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EM SA Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191201. 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 EM SA Implant System?

EM SA Implant System is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Hiossen, Inc.. The 510(k) number is K191201.

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

EM SA Implant System received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191201.

Who is the listed applicant for EM SA Implant System?

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

What is the FDA product code for EM SA Implant System?

The FDA product code for EM SA Implant System is DZE.

Other records listing Hiossen, Inc. 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.

K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK251427EK MULTI ANGLED 30 ABUTMENTK241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)K240232EK D3.3 and Ultra Wide ImplantsK233389EK Digital AbutmentsK222636ET Abutment System

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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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