PUR0901

GUDID 07332747178920

NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Plate

Nobel Biocare AB

Instrument tray, reusable
Primary Device ID07332747178920
NIH Device Record Keye0f9a288-a5bc-4c55-b9c6-265d27d91fe6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPUR0901
Catalog NumberPUR0901
Company DUNS353939929
Company NameNobel Biocare AB
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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
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
GS107332747178920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


[07332747178920]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-02
Device Publish Date2022-01-25

Devices Manufactured by Nobel Biocare AB

07332747207842 - Nobel Biocare®2025-04-03 Direct Abutment Engaging Gold/Plastic 5.0 HL/RPL
07332747207859 - Nobel Biocare®2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 5.0 HL/RPL
07332747207866 - Nobel Biocare®2025-04-03 Direct Abutment Engaging Gold/Plastic 6.0 HL/RPL
07332747207873 - Nobel Biocare®2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL
07332747208108 - Nobel Biocare®2025-04-03 Temporary Abutment Engaging Brånemark System® NP
07332747208115 - Nobel Biocare®2025-04-03 Temporary Abutment Non-Engaging Bmk Syst NP
07332747208122 - Nobel Biocare®2025-04-03 Temporary Abutment Engaging Brånemark System® RP
07332747208139 - Nobel Biocare®2025-04-03 Temporary Abutment Non-Engaging Bmk Syst RP

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