3Delta Tray Rose 1621620

GUDID EDEL16216200

3Delta Tray Rose 1000g

DeltaMed GmbH

Dental impression tray material

• Primary Device ID: EDEL16216200
• NIH Device Record Key: dbe9909a-2f48-48dd-81b8-ee571a877852
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Delta Tray Rose
• Version Model Number: 1621620
• Catalog Number: 1621620
• Company DUNS: 344805101
• Company Name: DeltaMed 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDEL16216200 [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: 2025-08-06
• Device Publish Date: 2025-07-29

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• EDEL16216200 - 3Delta Tray Rose: 2025-08-06 3Delta Tray Rose 1000g
• 04260635981600 - RS VIVO C&B Ultimate: 2025-07-03 RS VIVO C&B Ultimate A1 500g
• 04260635981617 - RS VIVO C&B Ultimate: 2025-07-03 RS VIVO C&B Ultimate A2 500g
• 04260635981624 - RS VIVO C&B Ultimate: 2025-07-03 RS VIVO C&B Ultimate A3 500g
• 04260635981631 - RS VIVO C&B Ultimate: 2025-07-03 RS VIVO C&B Ultimate B1 500g