Custom Legacy Titanium Abutment 8035-31-XX

GUDID 10841307116844

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307116844
NIH Device Record Key544daa29-24f1-4697-aa35-f7c680d1caf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Legacy Titanium Abutment
Version Model Number8035-31-XX
Catalog Number8035-31-XX
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS110841307116844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


[10841307116844]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-09-23

On-Brand Devices [Custom Legacy Titanium Abutment]

108413071168758530-31-XX
108413071168688057-31-XX
108413071168518045-31-XX
108413071168448035-31-XX

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