IU SB Abutment_hex Φ5.0

GUDID 08800026109242

WARANTEC.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 Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID08800026109242
NIH Device Record Key06cb49b0-2388-43ee-8386-a1bcd87dca00
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU SB Abutment_hex Φ5.0
Version Model NumberIUSB5024H
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
GS108800026109242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

Moist Heat or Steam Sterilization

[08800026109242]

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 Φ5.0]

08800026109280IUSB5064H
08800026109273IUSB5054H
08800026109266IUSB5044H
08800026109259IUSB5034H
08800026109242IUSB5024H
08800026109235IUSB5014H
08800026103097IUSB5067H
08800026103080IUSB5065H
08800026103073IUSB5057H
08800026103066IUSB5055H
08800026103059IUSB5047H
08800026103042IUSB5045H
08800026103035IUSB5037H
08800026103028IUSB5035H
08800026103011IUSB5027H
08800026103004IUSB5025H
08800026102991IUSB5017H
08800026102984IUSB5015H
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