KJ SUBMERGED SYSTEM - Solid Abutment

GUDID 08809488210886

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488210886
NIH Device Record Key66a0dcb4-ee02-4c20-8741-ceb751fd99e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKJ SUBMERGED SYSTEM - Solid Abutment
Version Model NumberSD24080S
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
GS108809488210886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488210886]

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 [KJ SUBMERGED SYSTEM - Solid Abutment]

08809488211753SDD37560S
08809488211746SDD36580S
08809488211739SDD36565S
08809488211722SDD36550S
08809488211715SDD35012S
08809488211708SDD35065S
08809488211692SDD35050S
08809488211685SDD34065S
08809488211678SDD26065S
08809488211661SDD26050S
08809488211654SDD25010S
08809488211647SDD25080S
08809488211630SDD25065S
08809488211623SDD25050S
08809488211616SDD24010S
08809488211609SDD24080S
08809488211593SDD24065S
08809488211586SDD23565S
08809488211579SDC37560S
08809488211562SDC36580S
08809488211555SDC36565S
08809488211548SDC36550S
08809488211531SDC35012S
08809488211524SDC35065S
08809488211517SDC35050S
08809488211500SDC34065S
08809488211494SDC26065S
08809488211487SDC26050S
08809488211470SDC25010S
08809488211463SDC25080S
08809488211456SDC25065S
08809488211449SDC25050S
08809488211432SDC24010S
08809488211425SDC24080S
08809488211418SDC24065S
08809488211401SDC23565S
08809488211395SDB37560S
08809488211388SDB36580S
08809488211371SDB36565S
08809488211364SDB36550S
08809488211357SDB35012S
08809488211340SDB35065S
08809488211333SDB35050S
08809488211326SDB34065S
08809488211319SDB26065S
08809488211302SDB26050S
08809488211296SDB25010S
08809488211289SDB25080S
08809488211272SDB25065S
08809488211265SDB25050S

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