Creative Color® Opaquer 6031B0

GUDID EDEL6031B00

Creative Color® Opaquer B-Zero, Syringe 2.5g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL6031B00
• NIH Device Record Key: 5ba0d423-fe6f-4f9c-8226-a9f1dcf35dd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creative Color® Opaquer
• Version Model Number: 6031B0
• Catalog Number: 6031B0
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796031B00 [Previous]
HIBCC	EDEL6031B00 [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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Creative Color® Opaquer]

• EDEL603A350: Creative Color® Opaquer A3.5, Syringe 2.5g
• EDEL6031WO0: Creative Color® Opaquer White, Syringe 2.5g
• EDEL6031D30: Creative Color® Opaquer D3-D4, Syringe 2.5g
• EDEL6031C40: Creative Color® Opaquer C4, Syringe 2.5g
• EDEL6031C20: Creative Color® Opaquer C2-C3, Syringe 2.5g
• EDEL6031C10: Creative Color® Opaquer C1-D2, Syringe 2.5g
• EDEL6031B30: Creative Color® Opaquer B3-B4, Syringe 2.5g
• EDEL6031B20: Creative Color® Opaquer B2, Syringe 2.5g
• EDEL6031B00: Creative Color® Opaquer B-Zero, Syringe 2.5g
• EDEL6031A40: Creative Color® Opaquer A4-A5, Syringe 2.5g
• EDEL6031A30: Creative Color® Opaquer A3, Syringe 2.5g
• EDEL6031A20: Creative Color® Opaquer A2-A2.5, Syringe 2.5g
• EDEL6031A10: Creative Color® Opaquer A1-B1-LO, Syringe 2.5g