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High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Den…

FDA 510(k)

Class I (US FDA 510(k))

510(k) K241074

by Foshan SOCO Precision Instrument Co., Ltd.

Identifiers

510(k) Number
K241074 FDA 510(k)
FDA Product Code
EFB FDA 510(k)
Models / Variants
Straight Handpieces: SCHD05-S FDA 510(k)
SCHD16-S FDA 510(k)
SCHD17-S FDA 510(k)
SCHD24-S FDA 510(k)
SCHD27-S Geared Angle Handpieces: SCHD05-C FDA 510(k)
SCHD06-C FDA 510(k)
SCHD16-C FDA 510(k)
SCHD17-C FDA 510(k)
SCHD24-C FDA 510(k)
SCHD27-C FDA 510(k)
SCHD29-S FDA 510(k)
SCHB4 FDA 510(k)
SCHB5 FDA 510(k)
SCHB20 FDA 510(k)
SCHB64 Air Motors: SCHD16-M FDA 510(k)
SCHD17-M FDA 510(k)
SCHD24-M FDA 510(k)
SCHD27-M FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.4200 FDA 510(k)
Regulation Number
872.4200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Den… by Foshan SOCO Precision Instrument Co., Ltd. — Class I — FDA_510K — listed…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foshan SOCO Precision Instrument Co., Ltd.

Sources (1)

  • FDA 510(k) K241074 24 fields · synced Jun 18, 2026