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FDA 510(k)

NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM

K-Number: K083252 · 2009-02-18

ApplicantDentalez Group, Stardental Division
Decision Date2009-02-18
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group, Stardental Division. It received FDA 510(k) clearance on 2009-02-18 under 510(k) number K083252. 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 NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM?

NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-18. The listed applicant is Dentalez Group, Stardental Division. The 510(k) number is K083252.

When did NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM receive FDA 510(k) clearance?

NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM received FDA 510(k) clearance on 2009-02-18, under 510(k) number K083252.

Who is the listed applicant for NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM?

The FDA 510(k) record lists Dentalez Group, Stardental Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM?

The FDA product code for NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM is EBW.

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Other records listing Dentalez Group, Stardental Division 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.

K130455430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

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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