3D Predict

GUDID D9393DS080

Orthodontic plastic aligner

3D SMILE USA, INC

Orthodontic appliance system, progressive

• Primary Device ID: D9393DS080
• NIH Device Record Key: 13203be8-eb3d-43e7-8c9d-1d2bdc2f4dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Predict
• Version Model Number: 3DS08
• Company DUNS: 117258618
• Company Name: 3D SMILE USA, INC
• 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: true
• 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

Customer Support Contacts

• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com
• Phone: +1 (920) 332 4344
• Email: support@3Dpredict.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9393DS080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200214

FDA Product Code

• NXC: Aligner, Sequential

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: 2020-08-14
• Device Publish Date: 2020-08-06