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510(k) K193264

Disposable High Speed Air Turbine Handpiece by Ningbo Hpdove Dental Instruments Co., Ltd. — Product Code EFB

K193264 is an FDA 510(k) premarket notification submitted by Ningbo Hpdove Dental Instruments Co., Ltd. for the device "Disposable High Speed Air Turbine Handpiece". The FDA issued a decision of Substantially Equivalent on August 11, 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
August 11, 2020
Date Received
November 26, 2019
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

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FDA data resources