Renamel® Gingafill® 609201

GUDID EDEL6092010

Renamel® Gingafill® Light Pink, Syringe 2g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6092010
• NIH Device Record Key: c83ed5b6-5ff7-4661-a3dd-0ef36a9054b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Gingafill®
• Version Model Number: 609201
• Catalog Number: 609201
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDEL6092010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854755

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Renamel® Gingafill®]

• EDEL6092030: Renamel® Gingafill® Dark Pink, Syringe 2g
• EDEL6092020: Renamel® Gingafill® Medium Pink, Syringe 2g
• EDEL6092010: Renamel® Gingafill® Light Pink, Syringe 2g
• EDEL6091050: Renamel® Gingafill® Blue, Syringe 3.5g
• EDEL6091040: Renamel® Gingafill® Orange, Syringe 3.5g
• EDEL6091030: Renamel® Gingafill® Dark Pink, Syringe 3.5g
• EDEL6091020: Renamel® Gingafill® Medium Pink, Syringe 3.5g
• EDEL6091010: Renamel® Gingafill® Light Pink, Syringe 3.5g