implant prosthetic kit

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Device Name

implant prosthetic kit

Model / Reference

TM-PRK-E, TM-SGT04, TM-SGT03, TM-SGT05, TM-SGT01, TOP WRENCH ，TM-D0007X, TM-PRK-C ，TM-D0010, TOP WRENCH

Primary DI / UDI-DI

06980140954064

Basic UDI-DI

698014095ipkYV

EMDN Code

Q010699 Materials for the preparation of custom-made dental devices - other

Device Class

Class I

Market of Registration

Austria

EUDAMED SRN

CN-MF-000057253

Authorised representative

SUNGO Europe B.V. NL-AR-000000247

• LED Curing Light

  Class I

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• implant prosthetic kit

  Class I

  CE/MDR

• Foshan Topmed

  Class I

  CE/MDR

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  FDA 510(k) K251388 Active Cleared 12 Jan 2026

• High speed air turbine handpiece

  Class I

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• LED Curing Light

  Class I

  CE/MDR

See all devices from Foshan Topmed Dental Co., Ltd →