Two-Piece Type Abutments

GUDID 08809488215256

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488215256
NIH Device Record Keya38a4168-d84a-4d1c-bd86-9dace31925ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwo-Piece Type Abutments
Version Model NumberTWA455540M
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
GS108809488215256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488215256]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-08-27

On-Brand Devices [Two-Piece Type Abutments]

08809488215768TWA705550R
08809488215751TWA705540R
08809488215744TWA705530R
08809488215737TWA705520R
08809488215720TWA705510R
08809488215713TWA607050R
08809488215706TWA607040R
08809488215690TWA607030R
08809488215683TWA607020R
08809488215676TWA607010R
08809488215669TWA605550R
08809488215652TWA605540R
08809488215645TWA605530R
08809488215638TWA605520R
08809488215621TWA605510R
08809488215614TWA604050R
08809488215607TWA604040R
08809488215591TWA604030R
08809488215584TWA604020R
08809488215577TWA604010R
08809488215560TWA507050R
08809488215553TWA507040R
08809488215546TWA507030R
08809488215539TWA507020R
08809488215522TWA507010R
08809488215515TWA505550R
08809488215508TWA505540R
08809488215492TWA505530R
08809488215485TWA505520R
08809488215478TWA505510R
08809488215461TWA504050R
08809488215454TWA504040R
08809488215447TWA504030R
08809488215430TWA504020R
08809488215423TWA504010R
08809488215416TWA457050R
08809488215409TWA457040R
08809488215393TWA457030R
08809488215386TWA457020R
08809488215379TWA457010R
08809488215362TWA455550R
08809488215355TWA455540R
08809488215348TWA455530R
08809488215331TWA455520R
08809488215324TWA455510R
08809488215317TWA457050M
08809488215300TWA457040M
08809488215294TWA457030M
08809488215287TWA457020M
08809488215270TWA457010M

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