PRO M CLASS

GUDID 08809394971352

The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.

SAEYANG MICROTECH CO.,LTD

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Primary Device ID08809394971352
NIH Device Record Key971092ba-aab8-4f81-936c-6b727affc32a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO M CLASS
Version Model NumberPRO M CLASS
Company DUNS631078094
Company NameSAEYANG MICROTECH CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394971352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


[08809394971352]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

Devices Manufactured by SAEYANG MICROTECH CO.,LTD

08809394971352 - PRO M CLASS2023-06-15The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.
08809394971352 - PRO M CLASS2023-06-15 The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Ada
08809394970881 - Ki-202020-10-01
08809394970997 - Endo E Class2020-10-01
08809394971345 - Endo A Class 2020-10-01

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