Icon-Etch Refill 220385

GUDID EDMG2203850

Infiltration Concept. Resin Infiltration - Smooth Surface. Refill etching gel Icon-Etch. Content: 3 syringes Icon-Etch @ 0.45 ml, accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental unfilled resin sealant/coating

• Primary Device ID: EDMG2203850
• NIH Device Record Key: 88da731d-1c42-4bc2-8a48-1bec378712f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon-Etch Refill
• Version Model Number: 220385
• Catalog Number: 220385
• 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: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *After use, dispose of the product in household waste.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2203850 [Primary]
HIBCC	EDMG2203851 [Package]; Package: [3 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-09
• Device Publish Date: 2019-07-01

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