ACRY PRINT RU-001 Temporary 0220001A2

GUDID EPRC0220001A2

ACRY PRINT RU-001 Temporary 1000g A2

pro3dure medical GmbH

Temporary dental crown/bridge resin

• Primary Device ID: EPRC0220001A2
• NIH Device Record Key: fec4d1e6-ea14-40ff-b344-6060af5e6b6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACRY PRINT RU-001 Temporary
• Version Model Number: 1000g ; A2
• Catalog Number: 0220001A2
• 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	EPRC0220001A2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201827

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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

On-Brand Devices [ACRY PRINT RU-001 Temporary]

• EPRC0220001A3: ACRY PRINT RU-001 Temporary 1000g A3
• EPRC0220001A2: ACRY PRINT RU-001 Temporary 1000g A2