Direct Abutment 43513

GUDID 07332747014167

Direct Abut Non-Eng Gold/Plastic 4.3 RPL

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747014167
NIH Device Record Key302307ea-0a8d-40e5-8e04-24c7111abb03
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect Abutment
Version Model Number43513
Catalog Number43513
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exempttrue
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

Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747014167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAAbutment, implant, dental, endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


[07332747014167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-09-17

On-Brand Devices [Direct Abutment]

07332747014167Direct Abut Non-Eng Gold/Plastic 4.3 RPL
07332747014150Direct Abut Non-Eng Gold/Plastic 3.5 RPL
07332747014129Direct Abut Eng Gold/Plastic 4.3 RPL
07332747014112Direct Abut Eng Gold/Plastic 3.5 RPL

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