Renamel® De-Mark™ 7011DM

GUDID EDEL7011DM0

Renamel® De-Mark™, Syringe 3g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL7011DM0
• NIH Device Record Key: b947e291-5df9-4dd8-a8ff-e1a4f505856a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® De-Mark™
• Version Model Number: 7011DM
• Catalog Number: 7011DM
• 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

• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7797011DM0 [Previous]
HIBCC	EDEL7011DM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921820

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2023-06-13
• Device Publish Date: 2023-06-05

Devices Manufactured by DeltaMed GmbH

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• EDEL6251030 - Insure® UNIVERSAL: 2024-09-02 Insure® UNIVERSAL Yellow Red Universal, Syringe 3g
• EDEL6251040 - Insure® UNIVERSAL: 2024-09-02 Insure® UNIVERSAL Grey Light, Syringe 3g
• EDEL6251050 - Insure® UNIVERSAL: 2024-09-02 Insure® UNIVERSAL White Opaque, Syringe 3g
• EDEL6251060 - Insure® UNIVERSAL: 2024-09-02 Insure® UNIVERSAL Yellow Opaque, Syringe 3g
• EDEL6251070 - Insure® UNIVERSAL: 2024-09-02 Insure® UNIVERSAL Pink Opaque, Syringe 3g
• EDEL625AMC0 - Insure® UNIVERSAL AutoMix: 2024-09-02 Insure® UNIVERSAL AutoMix Clear, Syringe 8g