Solid Abutment

GUDID 08800039302197

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 ID08800039302197
NIH Device Record Key6e055660-191a-44d1-a4f6-6d3dec9d23af
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolid Abutment
Version Model NumberHISS5514
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
GS108800039302197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


[08800039302197]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

On-Brand Devices [Solid Abutment]

08800039302425HISS6547
08800039302418HISS6537
08800039302401HISS6527
08800039302395HISS6517
08800039302388HISS6545
08800039302371HISS6535
08800039302364HISS6525
08800039302357HISS6515
08800039302340HISS6544
08800039302333HISS6534
08800039302326HISS6524
08800039302319HISS6514
08800039302302HISS5547
08800039302296HISS5537
08800039302289HISS5527
08800039302272HISS5517
08800039302265HISS5545
08800039302258HISS5535
08800039302241HISS5525
08800039302234HISS5515
08800039302227HISS5544
08800039302210HISS5534
08800039302203HISS5524
08800039302197HISS5514
08800039302180HISS4547
08800039302173HISS4537
08800039302166HISS4527
08800039302159HISS4517
08800039302142HISS4545
08800039302135HISS4535
08800039302128HISS4525
08800039302111HISS4515
08800039302104HISS4544
08800039302098HISS4534
08800039302081HISS4524
08800039302074HISS4514
08800039302067HISS4047
08800039302050HISS4037
08800039302043HISS4027
08800039302036HISS4017
08800039302029HISS4045
08800039302012HISS4035
08800039302005HISS4025
08800039301992HISS4015
08800039301985HISS4044
08800039301978HISS4034
08800039301961HISS4024
08800039301954HISS4014

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