Implant Studio

GUDID 05902729753845

3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

3shape A/S

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• Primary Device ID: 05902729753845
• NIH Device Record Key: 6d4a8d29-517e-4b2c-8c12-a328ba7fabb6
• Commercial Distribution Discontinuation: 2023-08-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Implant Studio
• Version Model Number: R1.4
• Company DUNS: 306826012
• Company Name: 3shape A/S
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729753845 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Implant Studio]

• 05902729753692: 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for u
• 05902729753845: 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for u