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FDA 510(k)

ZUGA DENTAL IMPLANT SYSTEM

K-Number: K122664 · 2013-04-30

ApplicantZuga Medical, Inc.
Decision Date2013-04-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZUGA DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zuga Medical, Inc.. It received FDA 510(k) clearance on 2013-04-30 under 510(k) number K122664. 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 ZUGA DENTAL IMPLANT SYSTEM?

ZUGA DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-30. The listed applicant is Zuga Medical, Inc.. The 510(k) number is K122664.

When did ZUGA DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ZUGA DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2013-04-30, under 510(k) number K122664.

Who is the listed applicant for ZUGA DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for ZUGA DENTAL IMPLANT SYSTEM?

The FDA product code for ZUGA DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

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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Other records listing Zuga Medical, 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.

K171197Zuga Dental 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.

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

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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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