Dental Handpiece

FDA 510(k) K093971 · North West Medical Instrument (Group) Co., Ltd.

Substantially Equivalent

510(k) numberK093971

Submission

Device name
Dental Handpiece
Applicant
North West Medical Instrument (Group) Co., Ltd.
Shanghai, CN
Received
December 24, 2009
Decision date
April 22, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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More from Ttbio Corp.

510(k)DeviceDecision
K080438Dental Unit with ChairEIA · Traditional 04/04/2008SE

Questions and answers

When was Dental Handpiece cleared by the FDA?

Dental Handpiece (K093971) received a 510(k) decision of Substantially Equivalent on April 22, 2010, 119 days after the submission was received.

What is the product code of K093971?

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