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510(k) K181691

High-speed air turbine handpiece / Low-speed air turbine handpiece by Foshan Wenjian Medical Instrument Co., Ltd. — Product Code EFB

K181691 is an FDA 510(k) premarket notification submitted by Foshan Wenjian Medical Instrument Co., Ltd. for the device "High-speed air turbine handpiece / Low-speed air turbine handpiece". The FDA issued a decision of Substantially Equivalent on May 26, 2020. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2020
Date Received
Jun 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type
510(k)

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FDA data resources