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FDA 510(k)

ETII SA FIXTURE SYSTEM

K-Number: K123471 · 2013-07-05

ApplicantHiossen, Inc.
Decision Date2013-07-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETII SA FIXTURE 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 2013-07-05 under 510(k) number K123471. 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 ETII SA FIXTURE SYSTEM?

ETII SA FIXTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-05. The listed applicant is Hiossen, Inc.. The 510(k) number is K123471.

When did ETII SA FIXTURE SYSTEM receive FDA 510(k) clearance?

ETII SA FIXTURE SYSTEM received FDA 510(k) clearance on 2013-07-05, under 510(k) number K123471.

Who is the listed applicant for ETII SA FIXTURE 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 ETII SA FIXTURE SYSTEM?

The FDA product code for ETII SA FIXTURE SYSTEM is DZE.

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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.

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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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