ACRY PRINT RU-005 Guide 0220005

GUDID EPRC0220005

ACRY PRINT RU-005 Guide 1000g Clear-Transparent

pro3dure medical GmbH

Dental appliance fabrication material, resin

• Primary Device ID: EPRC0220005
• NIH Device Record Key: b5109680-388b-4130-9d3f-95b23056e628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY PRINT RU-005 Guide
• Version Model Number: 1000g ; Clear-Transparent
• Catalog Number: 0220005
• Company DUNS: 312947842
• Company Name: pro3dure medical GmbH
• 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: true
• 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
HIBCC	EPRC0220005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211415

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by pro3dure medical GmbH

• EPRC0220001A2 - ACRY PRINT RU-001 Temporary: 2025-04-08 ACRY PRINT RU-001 Temporary 1000g A2
• EPRC0220001A3 - ACRY PRINT RU-001 Temporary: 2025-04-08 ACRY PRINT RU-001 Temporary 1000g A3
• EPRC0220003 - ACRY PRINT RU-003 Try-In: 2025-04-08 ACRY PRINT RU-003 Try-In 1000g A2
• EPRC0220004 - ACRY PRINT RU-004 Denture HI: 2025-04-08 ACRY PRINT RU-004 Denture HI 1000g Orange-Pink
• EPRC0220005 - ACRY PRINT RU-005 Guide: 2025-04-08ACRY PRINT RU-005 Guide 1000g Clear-Transparent
• EPRC0220005 - ACRY PRINT RU-005 Guide: 2025-04-08 ACRY PRINT RU-005 Guide 1000g Clear-Transparent
• EPRC768345 - UCAN Print Base: 2025-04-08 UCAN Print Base 1000g color 33
• EPRC768485 - UCAN Print Try-In: 2025-04-08 UCAN Print Try-In 1000g A2
• EPRC768486 - UCAN Print Splint: 2025-04-08 UCAN Print Splint 1000g Transparent