Magicore Solid Abutment

GUDID 08800090659902

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID08800090659902
NIH Device Record Key52ea3287-a15a-4a42-8dda-daf0d42df860
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagicore Solid Abutment
Version Model NumberMA5003
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
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 Numbertrue
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
GS108800090659902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


[08800090659902]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-18
Device Publish Date2020-09-10

On-Brand Devices [Magicore Solid Abutment]

08800039315463MA5502
08800039315456MA5006
08800039315449MA5004
08800039315432MA5002
08800039315425MA4506
08800039315418MA4504
08800039315401MA4502
08800090659919MA5005
08800090659902MA5003
08800090659896MA4505
08800090659889MA4503
08800039315555MA6006
08800039315548MA6005
08800039315531MA6004
08800039315524MA6003
08800039315517MA6002
08800039315500MA5506
08800039315494MA5505
08800039315487MA5504
08800039315470MA5503
08800039370301MA4005
08800039370288MA4003

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