RS VIVO C&B Ultimate RS006206

GUDID 04260635981631

RS VIVO C&B Ultimate B1 500g

DeltaMed GmbH

Dental appliance fabrication material, combination-material

• Primary Device ID: 04260635981631
• NIH Device Record Key: acf108b3-9731-4afc-b9e7-4095b19fc5de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS VIVO C&B Ultimate
• Version Model Number: RS006206
• Catalog Number: RS006206
• 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: false
• 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 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260635981631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243720

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: 2025-07-03
• Device Publish Date: 2025-06-25

On-Brand Devices [RS VIVO C&B Ultimate]

• 04260635981648: RS VIVO C&B Ultimate Bleach 500g
• 04260635981631: RS VIVO C&B Ultimate B1 500g
• 04260635981624: RS VIVO C&B Ultimate A3 500g
• 04260635981617: RS VIVO C&B Ultimate A2 500g
• 04260635981600: RS VIVO C&B Ultimate A1 500g