Abutment Fixation Screw 1000-20B

GUDID 10841307127383

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307127383
NIH Device Record Key03e98d53-4cd9-4dc3-805a-af1e0b4f79c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment Fixation Screw
Version Model Number1000-20B
Catalog Number1000-20B
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307127383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


[10841307127383]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-20
Device Publish Date2021-04-12

On-Brand Devices [Abutment Fixation Screw]

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

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