Abutment Fixation Screw 1000-01

GUDID 00841307129472

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841307129472
NIH Device Record Key94f533d2-1335-491a-9164-5957c6dfb7f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment Fixation Screw
Version Model Number1000-01
Catalog Number1000-01
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count2
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 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
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841307129472 [Unit of Use]
GS110841307129479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


[00841307129472]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-18
Device Publish Date2024-03-08

On-Brand Devices [Abutment Fixation Screw]

108413071086031000-01-1
108413071274061000-01B
108413071273831000-20B
008413071294721000-01

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