Icon® 220400

GUDID EDMG2204000

Infiltration Concept. Resin Infiltration - Proximal. Early arrest of caries - without drilling. Content: 2 treatment units (each contains 1 syringe Icon-Etch @ 0.30 ml, 1 syringe Icon-Dry @0.45 ml, 1 syringe Icon-Infiltrant @ 0.45 ml), accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental unfilled resin sealant/coating

• Primary Device ID: EDMG2204000
• NIH Device Record Key: ee1307aa-7313-4464-8858-32b7ecc4ea26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon®
• Version Model Number: 220400
• Catalog Number: 220400
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik 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: true
• 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

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2204000 [Primary]
HIBCC	EDMG2204001 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100062

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-14
• Device Publish Date: 2016-09-22

On-Brand Devices [Icon®]

• EDMG2204031: Infiltration Concept. Resin Infiltration - Smooth Surface. The effective approach to treating wi
• EDMG2204021: Infiltration Concept. Resin Infiltration - Smooth Surface. The effective approach to treating wi
• EDMG2204011: Infiltration Concept. Resin Infiltration - Proximal. Early arrest of caries - without drilling.
• EDMG2204000: Infiltration Concept. Resin Infiltration - Proximal. Early arrest of caries - without drilling.