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FDA 510(k)

High-speed Turbine Handpieces for Single Use

K-Number: K172543 · 2018-07-11

Decision Date2018-07-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

High-speed Turbine Handpieces for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K172543. 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 High-speed Turbine Handpieces for Single Use?

High-speed Turbine Handpieces for Single Use is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K172543.

When did High-speed Turbine Handpieces for Single Use receive FDA 510(k) clearance?

High-speed Turbine Handpieces for Single Use received FDA 510(k) clearance on 2018-07-11, under 510(k) number K172543.

Who is the listed applicant for High-speed Turbine Handpieces for Single Use?

The FDA 510(k) record lists Beijing Dongbo Dental Handpiece Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High-speed Turbine Handpieces for Single Use?

The FDA product code for High-speed Turbine Handpieces for Single Use is EFB.

Other records listing Beijing Dongbo Dental Handpiece Co., Ltd. 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.

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.

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.