Abutment Fixation Screw Extra Short 1000-01S

GUDID 00841307129489

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841307129489
NIH Device Record Keyee93c467-6a55-4e56-8617-2c4c8842f258
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment Fixation Screw Extra Short
Version Model Number1000-01S
Catalog Number1000-01S
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
GS100841307129489 [Unit of Use]
GS110841307129486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

Moist Heat or Steam Sterilization


[00841307129489]

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

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10841307103592 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103608 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103615 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD

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