IU SB Abutment_hex Φ6.0

GUDID 08800026103189

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026103189
NIH Device Record Key43f66331-04b2-48a8-a36f-0b4f8dc7a8e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_hex Φ6.0
Version Model NumberIUSB6055H
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
GS108800026103189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

Moist Heat or Steam Sterilization


[08800026103189]

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_hex Φ6.0]

08800026103219IUSB6067H
08800026103202IUSB6065H
08800026103196IUSB6057H
08800026103189IUSB6055H
08800026103172IUSB6047H
08800026103165IUSB6045H
08800026103158IUSB6037H
08800026103141IUSB6035H
08800026103134IUSB6027H
08800026103127IUSB6025H
08800026103110IUSB6017H
08800026103103IUSB6015H

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