FotoDent® tray2 D353003

GUDID E239D3530031

No.

Dreve Dentamid GmbH

Dental impression tray material

• Primary Device ID: E239D3530031
• NIH Device Record Key: 4de8bbf3-86d0-40b1-91c7-3af15654b15b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FotoDent® tray2
• Version Model Number: D353003
• Catalog Number: D353003
• Company DUNS: 388000846
• Company Name: Dreve Dentamid GmbH
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D3530031 [Primary]

FDA Product Code

• EBH: MATERIAL, IMPRESSION TRAY, 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: 2023-04-26
• Device Publish Date: 2023-04-18

On-Brand Devices [FotoDent® tray2]

• E239D3530031: No.
• E239D3530021: No.
• E239D3530011: No.