Enamelize™ 906101

GUDID EDEL9061010

Enamelize™, Tube 36g

DeltaMed GmbH

Dentifrice

• Primary Device ID: EDEL9061010
• NIH Device Record Key: a6d93206-120a-46d1-b7d1-98ae6a7140dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamelize™
• Version Model Number: 906101
• Catalog Number: 906101
• Company DUNS: 344805101
• Company Name: DeltaMed 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7799061010 [Previous]
HIBCC	EDEL9061010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862912

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Enamelize™]

• EDEL9061010: Enamelize™, Tube 36g
• EDEL9060000: Enamelize™, Syringe 3g