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FDA 510(k)

ET III SA ULTRA WIDE SYSTEM

K-Number: K103537 · 2011-03-10

ApplicantHiossen, Inc.
Decision Date2011-03-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ET III SA ULTRA WIDE 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 2011-03-10 under 510(k) number K103537. 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 ET III SA ULTRA WIDE SYSTEM?

ET III SA ULTRA WIDE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-10. The listed applicant is Hiossen, Inc.. The 510(k) number is K103537.

When did ET III SA ULTRA WIDE SYSTEM receive FDA 510(k) clearance?

ET III SA ULTRA WIDE SYSTEM received FDA 510(k) clearance on 2011-03-10, under 510(k) number K103537.

Who is the listed applicant for ET III SA ULTRA WIDE 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 ET III SA ULTRA WIDE SYSTEM?

The FDA product code for ET III SA ULTRA WIDE SYSTEM is DZE.

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Other records listing Hiossen, Inc. as applicant

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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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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