KJ SUBMERGED SYSTEM - SH Abutment

GUDID 08809488211968

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488211968
NIH Device Record Key84095f75-f2e4-4865-8006-573f0d867d4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKJ SUBMERGED SYSTEM - SH Abutment
Version Model NumberPTAB35054S
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
GS108809488211968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488211968]

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 - SH Abutment]

08809488211999PTAB36056S
08809488211982PTAB35056S
08809488211975PTAB36054S
08809488211968PTAB35054S
08809488211951PTAB55066S
08809488211944PTAB54066S
08809488211937PTAB55064S
08809488211920PTAB54064S
08809488211913PTAB24576S
08809488211906PTAB23566S
08809488211890PTAB24574S
08809488211883PTAB23564S
08809488211876PTAB3062S
08809488211869PTAB3061S
08809488211852PTAB3042S
08809488211845PTAB3041S
08809488211838PTAB2362S
08809488211821PTAB2361S
08809488211814PTAB2342S
08809488211807PTAB2341S
08809488211791PTAB2062S
08809488211784PTAB2061S
08809488211777PTAB2042S
08809488211760PTAB2041S

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