Extension Cemented Abutment

GUDID 08800049234006

DIO Corporation

Dental implant suprastructure, permanent, preformed
Primary Device ID08800049234006
NIH Device Record Keyfbe00a1f-55de-4aa0-9751-59294c90dd29
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtension Cemented Abutment
Version Model NumberAEI 48017[H]
Company DUNS631085206
Company NameDIO Corporation
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800049234006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


[08800049234006]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

On-Brand Devices [Extension Cemented Abutment]

08800049234181AEI 48037N[H]
08800049234105AEI 48027N[H]
08800049234020AEI 48017N[H]
08800049234006AEI 48017[H]
08800049233948AEI 48007N[H]

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