Angled Abutment

GUDID 08800070214046

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08800070214046
NIH Device Record Key20cb4e26-f62f-410b-916b-a3b12a22222e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngled Abutment
Version Model NumberAASRB52253
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS108800070214046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070214046]

Moist Heat or Steam Sterilization


[08800070214046]

Moist Heat or Steam Sterilization


[08800070214046]

Moist Heat or Steam Sterilization


[08800070214046]

Moist Heat or Steam Sterilization


[08800070214046]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-26
Device Publish Date2022-05-18

On-Brand Devices [Angled Abutment]

08800070215470AATRN60174S
08800070215463AATRN60172S
08800070215456AATRN50174S
08800070215449AATRN50172S
08800070215432AATRN45174S
08800070215425AATRN45172S
08800070215418AATRB60174S
08800070215401AATRB60172S
08800070215395AATRA60174S
08800070215388AATRA60172S
08800070215371AATRB50174S
08800070215364AATRB50172S
08800070215357AATRA50174S
08800070215340AATRA50172S
08800070215333AATRB45174S
08800070215326AATRB45172S
08800070215319AATRA45174S
08800070215302AATRA45172S
08800070215296AATMN45174S
08800070215289AATMN45172S
08800070215272AATMN40174S
08800070215265AATMN40172S
08800070215258AATMB45174S
08800070215241AATMB45172S
08800070215234AATMA45174S
08800070215227AATMA45172S
08800070215210AATMB40174S
08800070215203AATMB40172S
08800070215197AATMA40174S
08800070215180AATMA40172S
08800070214879AASRN57254S
08800070214862AASRN57253S
08800070214855AASRN57252S
08800070214848AASRN52254S
08800070214831AASRN52253S
08800070214824AASRN52252S
08800070214817AASRN45254S
08800070214800AASRN45253S
08800070214794AASRN45252S
08800070214787AASRN57154S
08800070214770AASRN57153S
08800070214763AASRN57152S
08800070214756AASRN52154S
08800070214749AASRN52153S
08800070214732AASRN52152S
08800070214725AASRN45154S
08800070214718AASRN45153S
08800070214701AASRN45152S
08800070214695AASRB57254S
08800070214688AASRB57253S

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