Dentbird Solution

GUDID 08809953520007

Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).

IMAGOWORKS Inc.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 08809953520007
• NIH Device Record Key: 78993b31-963a-45ab-9b1e-76844ac1c2f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentbird Solution
• Version Model Number: Dentbird Crown V.2.x.x
• Company DUNS: 963215271
• Company Name: IMAGOWORKS Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809953520007 [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: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by IMAGOWORKS Inc.

• 08809953520021 - Dentbird Crown: 2024-10-07 Dentbird Crown is a software intended to support dental prostheses(crowns, bridges, in/onlays) design using 3D data from a patie
• 08809953520014 - Dentbird Crown: 2023-11-06 Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives
• 08809953520007 - Dentbird Solution: 2023-10-12Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj).
• 08809953520007 - Dentbird Solution: 2023-10-12 Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives