Circle One

GUDID 03760434300004

Circle ONE Design is a software device intended to support the design of the following dental prostheses: full crowns, partial crowns (onlay, inlay, overlay), veneers. It allows the import of 3D intraoral scan data and provides automated prosthetic design proposals that can be reviewed, adjusted and exported for manufacturing.

CIRCLE ANATOSCOPE INTUITIVE DESIGN

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 03760434300004
• NIH Device Record Key: be384216-267d-413e-af20-273e139ebda6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circle One
• Version Model Number: V.1.X.X
• Company DUNS: 268404822
• Company Name: CIRCLE ANATOSCOPE INTUITIVE DESIGN
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760434300004 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2025-09-05
• Device Publish Date: 2025-08-28