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 IDEDMG2132008
NIH Device Record Keyab316d19-fd98-4358-9246-a7f6c19900f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempoCemID
Version Model Number213200
Catalog Number213200
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature. Protect against exposure to direct sunlight!

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2132000 [Primary]
HIBCCEDMG2132001 [Package]
Contains: EDMG2132000
Package: [1 Units]
In Commercial Distribution
HIBCCEDMG2132008 [Package]
Contains: EDMG2132001
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-08

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