Renamel® NANO™ +plus 6005B0

GUDID EDEL6005B00

Renamel® NANO™ +plus Body B-Zero, Syringe 5g

DeltaMed GmbH

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: EDEL6005B00
• NIH Device Record Key: a8ca3410-38ea-4610-ad66-809fd808a7b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® NANO™ +plus
• Version Model Number: 6005B0
• Catalog Number: 6005B0
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796005B00 [Previous]
HIBCC	EDEL6005B00 [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