One-Piece Type Abutments

GUDID 08809488214280

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488214280
NIH Device Record Key103051e8-e742-43fc-932d-c3466776b928
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne-Piece Type Abutments
Version Model NumberOPA404020M
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
GS108809488214280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488214280]

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 [One-Piece Type Abutments]

08809488215218OPA705550R
08809488215201OPA705540R
08809488215195OPA705530R
08809488215188OPA705520R
08809488215171OPA705510R
08809488215164OPA607050R
08809488215157OPA607040R
08809488215140OPA607030R
08809488215133OPA607020R
08809488215126OPA607010R
08809488215119OPA605550R
08809488215102OPA605540R
08809488215096OPA605530R
08809488215089OPA605520R
08809488215072OPA605510R
08809488215065OPA604050R
08809488215058OPA604040R
08809488215041OPA604030R
08809488215034OPA604020R
08809488215027OPA604010R
08809488215010OPA507050R
08809488215003OPA507040R
08809488214990OPA507030R
08809488214983OPA507020R
08809488214976OPA507010R
08809488214969OPA505550R
08809488214952OPA505540R
08809488214945OPA505530R
08809488214938OPA505520R
08809488214921OPA505510R
08809488214914OPA504050R
08809488214907OPA504040R
08809488214891OPA504030R
08809488214884OPA504020R
08809488214877OPA504010R
08809488214860OPA457050R
08809488214853OPA457040R
08809488214846OPA457030R
08809488214839OPA457020R
08809488214822OPA457010R
08809488214815OPA455550R
08809488214808OPA455540R
08809488214792OPA455530R
08809488214785OPA455520R
08809488214778OPA455510R
08809488214761OPA454050R
08809488214754OPA454040R
08809488214747OPA454030R
08809488214730OPA454020R
08809488214723OPA454010R

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