Adhesive 4405

GUDID 07630243601684

COLTENE ADHESIVE AC 10ML

Dent4You AG

Silicone dental impression material

• Primary Device ID: 07630243601684
• NIH Device Record Key: 4af0f58e-49a9-4735-b821-2e840e92c010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adhesive
• Version Model Number: 4405
• Catalog Number: 4405
• Company DUNS: 480152811
• Company Name: Dent4You AG
• 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: false
• 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
GS1	07630243601684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220097

FDA Product Code

• ELW: Material, Impression

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: 2026-02-18
• Device Publish Date: 2026-02-10

On-Brand Devices [Adhesive]

• 07630243601691: COLTENE ADHESIVE 10ML
• 07630243601684: COLTENE ADHESIVE AC 10ML