IU SB Abutment_Non hex Φ6.0

GUDID 08800026104124

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026104124
NIH Device Record Key24875ebe-57fb-497b-96e4-63e5c555db06
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_Non hex Φ6.0
Version Model NumberIUSB6045N
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
GS108800026104124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

Moist Heat or Steam Sterilization


[08800026104124]

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_Non hex Φ6.0]

08800026104179IUSB6067N
08800026104162IUSB6065N
08800026104155IUSB6057N
08800026104148IUSB6055N
08800026104131IUSB6047N
08800026104124IUSB6045N
08800026104117IUSB6037N
08800026104100IUSB6035N
08800026104094IUSB6027N
08800026104087IUSB6025N
08800026104070IUSB6017N
08800026104063IUSB6015N

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