Ki-20

GUDID 08809394970881

SAEYANG MICROTECH CO.,LTD

Dental power tool system handpiece, line-powered
Primary Device ID08809394970881
NIH Device Record Keyfa300a79-2af2-4fa6-8186-77cb62744ab6
Commercial Distribution StatusIn Commercial Distribution
Brand NameKi-20
Version Model NumberKi-20
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394970881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, Foot, Handpiece And Cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

Devices Manufactured by SAEYANG MICROTECH CO.,LTD

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
08809394970881 - Ki-202020-10-01
08809394970997 - Endo E Class2020-10-01
08809394971345 - Endo A Class 2020-10-01

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