Renamel® NANO™ +plus 6005S2

GUDID EDEL6005S20

Renamel® NANO™ +plus SuperBrite 2, Syringe 5g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6005S20
• NIH Device Record Key: 7d06f200-f770-4123-83a7-9cf93b17cd2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® NANO™ +plus
• Version Model Number: 6005S2
• Catalog Number: 6005S2
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796005S20 [Previous]
HIBCC	EDEL6005S20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163480

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® NANO™ +plus]

• EDEL6006WI0: Renamel® NANO™ +plus White Transparent Incisal, 10 Compules
• EDEL6006S30: Renamel® NANO™ +plus SuperBrite 3, 10 Compules
• EDEL6006S20: Renamel® NANO™ +plus SuperBrite 2, 10 Compules
• EDEL6006S10: Renamel® NANO™ +plus SuperBrite 1, 10 Compules
• EDEL6006MI0: Renamel® NANO™ +plus Medium Incisal, 10 Compules
• EDEL6006LI0: Renamel® NANO™ +plus Light Incisal, 10 Compules
• EDEL6006D30: Renamel® NANO™ +plus Body D3, 10 Compules
• EDEL6006D20: Renamel® NANO™ +plus Body D2, 10 Compules
• EDEL6006C40: Renamel® NANO™ +plus Body C4, 10 Compules
• EDEL6006C30: Renamel® NANO™ +plus Body C3, 10 Compules
• EDEL6006C20: Renamel® NANO™ +plus Body C2, 10 Compules
• EDEL6006C10: Renamel® NANO™ +plus Body C1, 10 Compules
• EDEL6006B20: Renamel® NANO™ +plus Body B2, 10 Compules
• EDEL6006B10: Renamel® NANO™ +plus Body B1, 10 Compules
• EDEL6006B00: Renamel® NANO™ +plus Body B-Zero, 10 Compules
• EDEL6006A40: Renamel® NANO™ +plus Body A4, 10 Compules
• EDEL6006A30: Renamel® NANO™ +plus Body A3, 10 Compules
• EDEL6006A20: Renamel® NANO™ +plus Body A2, 10 Compules
• EDEL6006A10: Renamel® NANO™ +plus Body A1, 10 Compules
• EDEL6006350: Renamel® NANO™ +plus Body A3.5, 10 Compules
• EDEL6005WI0: Renamel® NANO™ +plus White Transparent Incisal, Syringe 5g
• EDEL6005S30: Renamel® NANO™ +plus SuperBrite 3, Syringe 5g
• EDEL6005S20: Renamel® NANO™ +plus SuperBrite 2, Syringe 5g
• EDEL6005S10: Renamel® NANO™ +plus SuperBrite 1, Syringe 5g
• EDEL6005MI0: Renamel® NANO™ +plus Medium Incisal, Syringe 5g
• EDEL6005LI0: Renamel® NANO™ +plus Light Incisal, Syringe 5g
• EDEL6005D30: Renamel® NANO™ +plus Body D3, Syringe 5g
• EDEL6005D20: Renamel® NANO™ +plus Body D2, Syringe 5g
• EDEL6005C40: Renamel® NANO™ +plus Body C4, Syringe 5g
• EDEL6005C30: Renamel® NANO™ +plus Body C3, Syringe 5g
• EDEL6005C20: Renamel® NANO™ +plus Body C2, Syringe 5g
• EDEL6005C10: Renamel® NANO™ +plus Body C1, Syringe 5g
• EDEL6005B20: Renamel® NANO™ +plus Body B2, Syringe 5g
• EDEL6005B10: Renamel® NANO™ +plus Body B1, Syringe 5g
• EDEL6005B00: Renamel® NANO™ +plus Body B-Zero, Syringe 5g
• EDEL6005A40: Renamel® NANO™ +plus Body A4, Syringe 5g
• EDEL6005A30: Renamel® NANO™ +plus Body A3, Syringe 5g
• EDEL6005A20: Renamel® NANO™ +plus Body A2, Syringe 5g
• EDEL6005A10: Renamel® NANO™ +plus Body A1, Syringe 5g
• EDEL6005350: Renamel® NANO™ +plus Body A3.5, Syringe 5g