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FDA 510(k)

Maxima Electric System

K-Number: K180845 · 2019-07-25

ApplicantHandpiece Headquarters - Hpr, Inc.
Decision Date2019-07-25
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Maxima Electric System is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters - Hpr, Inc.. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K180845. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maxima Electric System?

Maxima Electric System is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Handpiece Headquarters - Hpr, Inc.. The 510(k) number is K180845.

When did Maxima Electric System receive FDA 510(k) clearance?

Maxima Electric System received FDA 510(k) clearance on 2019-07-25, under 510(k) number K180845.

Who is the listed applicant for Maxima Electric System?

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

What is the FDA product code for Maxima Electric System?

The FDA product code for Maxima Electric System is EBW.

Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, 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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