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FDA 510(k)

JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU

K-Number: K062740 · 2006-11-02

ApplicantJindell Medical Instruments Co., Ltd.
Decision Date2006-11-02
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU is the device name listed in this FDA 510(k) record. The listed applicant is Jindell Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K062740. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU?

JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Jindell Medical Instruments Co., Ltd.. The 510(k) number is K062740.

When did JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU receive FDA 510(k) clearance?

JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU received FDA 510(k) clearance on 2006-11-02, under 510(k) number K062740.

Who is the listed applicant for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU?

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

What is the FDA product code for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU?

The FDA product code for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU is EFB.

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Related Devices (Code: EFB)

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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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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