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510(k) K240337

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) by Guangdong Jinme Medical Technology Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2024
Date Received
February 5, 2024
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

Other clearances by Guangdong Jinme Medical Technology Co., Ltd.

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  • K170236 — Dental Low-speed Turbine Handpiece (November 21, 2017)
  • K170229 — Dental High-speed Turbine Handpiece (November 8, 2017)

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