PUR0101

GUDID 07332747149999

Trefoil™ PureSet Plate

Nobel Biocare AB

Instrument tray, reusable

• Primary Device ID: 07332747149999
• NIH Device Record Key: c95b5ab4-4d34-4749-91f6-af175722f21c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PUR0101
• Catalog Number: PUR0101
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747149999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181075

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

[07332747149999]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-02
• Device Publish Date: 2022-01-25

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