Helioseal/Clear/F/F Plus 686770AN

GUDID 07615208472653

Helioseal F Plus Refill 5x1.25g

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

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Primary Device ID	07615208472653
NIH Device Record Key	047d0e4a-7dee-4ec9-80c6-45d623c89d7a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Helioseal/Clear/F/F Plus
Version Model Number	686770AN
Catalog Number	686770AN
Company DUNS	448015938
Company Name	IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Device Count	5
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	07615208294200 [Primary]
GS1	07615208472653 [Unit of Use]
HIBCC	DVIV686770AN1 [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