Helioseal/Clear/F/F Plus 686771AN

GUDID 07615208453492

Helioseal F Plus Cavifil Refill 50x0.1g

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

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• Primary Device ID: 07615208453492
• NIH Device Record Key: bf017e36-64a1-4587-9db7-ca7b67eb5983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helioseal/Clear/F/F Plus
• Version Model Number: 686771AN
• Catalog Number: 686771AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 50
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07615208294194 [Primary]
GS1	07615208453492 [Package]; Contains: 07615208294194; Package: [10 Units]; In Commercial Distribution
GS1	07615208472660 [Unit of Use]
HIBCC	DVIV686771AN1 [Previous]

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