TempoCemID 213200

GUDID EDMG2132008

Temporary cement smartmix system. Invisible under restorations, yet detectable for excess removal. Content: 1 syringe @ 5ml, Accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin

• Primary Device ID: EDMG2132008
• NIH Device Record Key: ab316d19-fd98-4358-9246-a7f6c19900f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TempoCemID
• Version Model Number: 213200
• Catalog Number: 213200
• 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 *Store in a dry place at room temperature. Protect against exposure to direct sunlight!

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2132000 [Primary]
HIBCC	EDMG2132001 [Package]; Contains: EDMG2132000; Package: [1 Units]; In Commercial Distribution
HIBCC	EDMG2132008 [Package]; Contains: EDMG2132001; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160443

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: 2017-03-08

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