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Zuga Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122664

by Zuga Medical, Inc.

Identifiers

510(k) Number
K122664 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zuga Dental Implant System is a dental implant system. It is classified under the product code DZE. The system is used in dental implant procedures.

The Zuga Dental Implant System is supplied by Zuga Medical, Inc. It has been found to be substantially equivalent and has received FDA 510K authorization. The system is associated with the k number K122664.

Frequently asked questions

What is the Zuga Dental Implant System used for?

The Zuga Dental Implant System is used in dental implant procedures, providing a solution for patients in need of dental implants.

Is the Zuga Dental Implant System sterile?

The device data does not explicitly state the sterility of the Zuga Dental Implant System, but it is typically expected for such medical devices to be supplied sterile.

What is the regulatory status of the Zuga Dental Implant System?

The Zuga Dental Implant System has received FDA 510K authorization, indicating it has been found substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Zuga Dental Implants | SpotImplant, Zuga Medical, Inc. | Cleveland, OH, USA Startup - Gust, Zuga Medical, Inc - LinkedIn

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zuga Medical, Inc.

Sources (1)

  • FDA 510(k) K122664 24 fields · synced Sep 27, 2026