29042

GUDID 17332747000013

Gold Coping Multi-unit 5/pkg

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID17332747000013
NIH Device Record Keyd9d115b8-ab8d-4438-b1c1-65c712e152bd
Commercial Distribution StatusIn Commercial Distribution
Version Model Number29042
Catalog Number29042
Company DUNS353939929
Company NameNobel Biocare AB
Device Count5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747150407 [Unit of Use]
GS117332747000013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

Moist Heat or Steam Sterilization


[17332747000013]

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

Devices Manufactured by Nobel Biocare AB

07332747224665 - NA2025-05-27 Temporary Prosthetic Screw Multi-unit Abutment
07332747207828 - Nobel Biocare®2025-05-26 Abutment Screw TorqTite 3.8/4.3/4.5/5.0/6.0 HL/RPL
07332747207835 - NA2025-05-26 Implant Analog 5.0 HL/RPL
07332747207880 - NA2025-05-26 Implant Analog 6.0 HL/RPL
07332747150384 - Nobel Biocare®2025-05-26 Prosthetic screw UniGrip™ Novum 2-pack
07332747150391 - Nobel Biocare®2025-05-26 Lower bar screw UniGrip™ Novum 3-pack
07332747207910 - NA2025-05-26 Replica Fixture Novum
07332747207927 - Brånemark System®2025-05-26 Screw Ceramic Abutment Bmk Syst RP

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