Cemented Abutment

GUDID 08800070209974

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 ID08800070209974
NIH Device Record Keyd872c989-a1bf-4093-bb44-6a864a933873
Commercial Distribution StatusIn Commercial Distribution
Brand NameCemented Abutment
Version Model NumberCATRN50205
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
GS108800070209974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070209974]

Moist Heat or Steam Sterilization


[08800070209974]

Moist Heat or Steam Sterilization


[08800070209974]

Moist Heat or Steam Sterilization


[08800070209974]

Moist Heat or Steam Sterilization


[08800070209974]

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 [Cemented Abutment]

08800070212424CATRN70705S
08800070212417CATRN70605S
08800070212400CATRN70505S
08800070212394CATRN70405S
08800070212387CATRN70305S
08800070212370CATRN70205S
08800070212363CATRN70105S
08800070212356CATRN70704S
08800070212349CATRN70604S
08800070212332CATRN70504S
08800070212325CATRN70404S
08800070212318CATRN70304S
08800070212301CATRN70204S
08800070212295CATRN70104S
08800070212288CATRN60707S
08800070212271CATRN60607S
08800070212264CATRN60507S
08800070212257CATRN60407S
08800070212240CATRN60307S
08800070212233CATRN60207S
08800070212226CATRN60107S
08800070212219CATRN60705S
08800070212202CATRN60605S
08800070212196CATRN60505S
08800070212189CATRN60405S
08800070212172CATRN60305S
08800070212165CATRN60205S
08800070212158CATRN60105S
08800070212141CATRN60704S
08800070212134CATRN60604S
08800070212127CATRN60504S
08800070212110CATRN60404S
08800070212103CATRN60304S
08800070212097CATRN60204S
08800070212080CATRN60104S
08800070212073CATRN50707S
08800070212066CATRN50607S
08800070212059CATRN50507S
08800070212042CATRN50407S
08800070212035CATRN50307S
08800070212028CATRN50207S
08800070212011CATRN50107S
08800070212004CATRN50705S
08800070211991CATRN50605S
08800070211984CATRN50505S
08800070211977CATRN50405S
08800070211960CATRN50305S
08800070211953CATRN50205S
08800070211946CATRN50105S
08800070211939CATRN50704S

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