Kerator

GUDID 08809488212200

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488212200
NIH Device Record Keycde8d47c-1b52-4ff3-86c6-b739834bb0bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerator
Version Model NumberB507
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
GS108809488212200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488212200]

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]

08809488213009KMD619
08809488212996CDPH2
08809488212989T407
08809488212972T406
08809488212965T405
08809488212958T404
08809488212941T403
08809488212934T402
08809488212927T401
08809488212910PA456
08809488212903PA455
08809488212897PA454
08809488212880PA453
08809488212873PA452
08809488212866PA451
08809488212859PA450
08809488212842PA356
08809488212835PA355
08809488212828PA354
08809488212811PA353
08809488212804PA352
08809488212798PA351
08809488212781PA350
08809488212774BC307
08809488212767BC306
08809488212750BC305
08809488212743BC304
08809488212736BC303
08809488212729BC302
08809488212712BC301
08809488212705BC207
08809488212699BC206
08809488212682BC205
08809488212675BC204
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08809488212651BC202
08809488212644BC201
08809488212637SRS506
08809488212620SRS505
08809488212613SRS504
08809488212606SRS503
08809488212590SRS502
08809488212583SRS501
08809488212576SRS500
08809488212569SRS457
08809488212552SRS456
08809488212545SRS455
08809488212538SRS454
08809488212521SRS453
08809488212514SRS452

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