IPS CaseDesigner 300011_V1.3_WIN64

GUDID 07332747126969

IPS CaseDesigner 1.3 for Windows 64-bit

Nobel Biocare AB

Dental treatment application software

• Primary Device ID: 07332747126969
• NIH Device Record Key: 7864a397-cda1-4583-8fcf-3259fe2b9938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IPS CaseDesigner
• Version Model Number: 300011_V1.3_WIN64
• Catalog Number: 300011_V1.3_WIN64
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747126969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161634

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2018-02-02

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