Constic B1 220704

GUDID EDMG2207041

Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: B1

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental pit/fissure sealant

• Primary Device ID: EDMG2207041
• NIH Device Record Key: fd7ff18c-2bca-4b05-a16d-18fa0ca5bd9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constic B1
• Version Model Number: 220704
• Catalog Number: 220704
• 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

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2207040 [Primary]
HIBCC	EDMG2207041 [Package]; Contains: EDMG2207040; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102603

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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