Helioseal/Clear/F/F Plus 686772AN

GUDID 07615208445565

Helioseal F Plus Refill 1x1g

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental composite resin

• Primary Device ID: 07615208445565
• NIH Device Record Key: 2b6eb256-65d8-4fa6-be20-f8554aab1674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helioseal/Clear/F/F Plus
• Version Model Number: 686772AN
• Catalog Number: 686772AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07615208294187 [Primary]
GS1	07615208445565 [Package]; Contains: 07615208294187; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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: 2024-04-12
• Device Publish Date: 2024-04-04

On-Brand Devices [Helioseal/Clear/F/F Plus]

• 07615208447071: Helioseal Clear Refill 1x1.25 g
• 07615208445572: Helioseal F Plus Refill 1x1.25g
• 07615208472653: Helioseal F Plus Refill 5x1.25g
• 07615208453492: Helioseal F Plus Cavifil Refill 50x0.1g
• 07615208445565: Helioseal F Plus Refill 1x1g