SMARTbase MUA Cylinder Pink Hue

GUDID 10841307123606

Incl: Fixation Screw [1000-25B] SMARTbase Cylinder

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID10841307123606
NIH Device Record Key6c8319c6-5d96-4847-a2fe-0bec7f0c9dc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMARTbase MUA Cylinder Pink Hue
Version Model Number1000-69BP
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 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
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307123606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


[10841307123606]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-04-25

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

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00841307129526 - Dual-Grip™ Long Fixation Screw2024-03-20
00841307129533 - Dual-Grip™ Long Fixation Screw2024-03-20
00841307129540 - Long Fixation Screw2024-03-20
00841307129557 - Fixation Screw2024-03-20
00841307129571 - Duo-Grip™ Long Fixation Screw2024-03-20
00841307129588 - Duo-Grip™ Fixation Screw2024-03-20
00841307129595 - Duo-Grip™ Fixation Screw Extra Short2024-03-20

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