36664

GUDID 07332747034288

Temporary Abutment Engaging CC RP

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747034288
NIH Device Record Keye2069157-e88a-40c2-84b7-3839ede9daf7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number36664
Catalog Number36664
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747034288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

Moist Heat or Steam Sterilization


[07332747034288]

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.