Kerator Abutment

GUDID 08809488213092

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488213092
NIH Device Record Key317d017e-20c5-4349-a42b-019ee818996f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerator Abutment
Version Model NumberAR400
Company DUNS688476027
Company NameKJMEDITECH.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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809488213092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488213092]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-08-26

On-Brand Devices [Kerator Abutment]

08809488213306AT407
08809488213290AT406
08809488213283AT405
08809488213276AT404
08809488213269AT403
08809488213252AT402
08809488213245AT401
08809488213238AT307
08809488213221AT306
08809488213214AT305
08809488213207AT304
08809488213191AT303
08809488213184AT302
08809488213177AT301
08809488213160AR407
08809488213153AR406
08809488213146AR405
08809488213139AR404
08809488213122AR403
08809488213115AR402
08809488213108AR401
08809488213092AR400
08809488213085AO407
08809488213078AO406
08809488213061AO405
08809488213054AO404
08809488213047AO403
08809488213030AO402
08809488213023AO401

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