TempoCem®NE Automix 110302

GUDID EDMG1103028

Temporary cement automix system, eugenol free. The temporary cement that keeps its promise. Content: 1 cartridge @ 25 ml paste, accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG1103028
• NIH Device Record Key: d94a4f24-e8e8-4862-bd63-c08117ad04c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TempoCem®NE Automix
• Version Model Number: 110302
• Catalog Number: 110302
• 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	EDMG1103020 [Primary]
HIBCC	EDMG1103021 [Package]; Contains: EDMG1103020; Package: [1 Units]; In Commercial Distribution
HIBCC	EDMG1103028 [Package]; Contains: EDMG1103021; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970774

FDA Product Code

• EMA: Cement, Dental

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: 2016-09-23

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