Dentaprint S3DTIR

GUDID E235S3DTIR0

Dentaprint 3D Try-In Resin (A1) Sample

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, resin

• Primary Device ID: E235S3DTIR0
• NIH Device Record Key: 71fbd04b-e028-44b3-9910-a231147e6f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentaprint
• Version Model Number: S3DTIR
• Catalog Number: S3DTIR
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235S3DTIR0 [Primary]

FDA Product Code

• ELM: Denture, plastic, teeth

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: 2025-09-03
• Device Publish Date: 2025-08-26

On-Brand Devices [Dentaprint]

• E235S3DTIR0: Dentaprint 3D Try-In Resin (A1) Sample
• E235S3DSGR0: Dentaprint 3D Surgical Guide Resin Sample
• E235S3DOR0: Dentaprint 3D Ortho Model Resin Sample
• E235S3DMR0: Dentaprint 3D Model Resin Sample
• E235S3DCR0: Dentaprint 3D Cast Resin Sample