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FDA 510(k)

X-CUBE

K-Number: K092758 · 2009-09-21

ApplicantSaeshin Precision Co., Ltd.
Decision Date2009-09-21
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-CUBE is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2009-09-21 under 510(k) number K092758. 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 X-CUBE?

X-CUBE is a medical device that received FDA 510(k) clearance on 2009-09-21. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K092758.

When did X-CUBE receive FDA 510(k) clearance?

X-CUBE received FDA 510(k) clearance on 2009-09-21, under 510(k) number K092758.

Who is the listed applicant for X-CUBE?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-CUBE?

The FDA product code for X-CUBE is EBW.

Other records listing Saeshin Precision Co., Ltd. as applicant

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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

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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