PRO3DURE GR-19 OA D1001610

GUDID EPRCD1001610

printodent GR-19 OA

pro3dure medical GmbH

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: EPRCD1001610
• NIH Device Record Key: a4441b67-6942-40fa-b690-ec8dcd47ce2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO3DURE GR-19 OA
• Version Model Number: 500 g - Light blue-transparent
• Catalog Number: D1001610
• 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: true
• 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

Customer Support Contacts

• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCD1001610 [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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [PRO3DURE GR-19 OA]

• EPRCD1001493: printodent GR-19 OA
• EPRCD1001492: printodent GR-19 OA
• EPRCD1001491: printodent GR-19 OA
• EPRCD1001611: printodent GR-19 OA
• EPRCD1001610: printodent GR-19 OA
• EPRCD1001609: printodent GR-19 OA