Hi-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D

FDA 510(k) K071561 · Beijing North Pole Dental Handpiece Co., Ltd.

Substantially Equivalent

510(k) numberK071561

Submission

Device name
Hi-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
Applicant
Beijing North Pole Dental Handpiece Co., Ltd.
Shanghai, CN
Received
June 7, 2007
Decision date
October 12, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Hi-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D cleared by the FDA?

Hi-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D (K071561) received a 510(k) decision of Substantially Equivalent on October 12, 2007, 127 days after the submission was received.

What is the product code of K071561?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.