IU SB Abutment Φ6.0

GUDID 08800026103639

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026103639
NIH Device Record Keyca0d80ae-5302-4a5a-81c8-1b50d070cfda
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment Φ6.0
Version Model NumberIUSB6037
Company DUNS688857820
Company NameWARANTEC.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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026103639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


[08800026103639]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-20
Device Publish Date2023-04-12

On-Brand Devices [IU SB Abutment Φ6.0]

08800026103691IUSB6067
08800026103684IUSB6065
08800026103677IUSB6057
08800026103660IUSB6055
08800026103653IUSB6047
08800026103646IUSB6045
08800026103639IUSB6037
08800026103622IUSB6035
08800026103615IUSB6027
08800026103608IUSB6025
08800026103592IUSB6017
08800026103585IUSB6015

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