Hybrid Link UNHL 40551H

GUDID 08800049278901

DIO Corporation

Dental implant suprastructure, permanent, preformed
Primary Device ID08800049278901
NIH Device Record Key9144589e-cd83-4356-9678-7ef571a9f97b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybrid Link
Version Model NumberUNHL 40551H
Catalog NumberUNHL 40551H
Company DUNS631085206
Company NameDIO Corporation
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 Numbertrue
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
GS108800049278901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800049278901]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

On-Brand Devices [Hybrid Link]

08800049278925UNHL 40553H
08800049278918UNHL 40552H
08800049278901UNHL 40551H
08800049278895UNHL 40403H
08800049278888UNHL 40402H
08800049278871UNHL 40401H

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