TempoCem® Automix

Primary DI
EDMG1103000
Brand
TempoCem® Automix
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
110300
Catalog number
110300
Device description
Temporary cement automix system. The temporary cement that keeps its promise. Content: 1 cartridge @ 25 ml paste, accessories.
Published
2020-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110759000TEMPOCEMDmg USA, Inc.2011-06-10EMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG1103001PackageHIBCC1In Commercial Distribution
EDMG1103008PackageHIBCC12In Commercial Distribution
EDMG1103000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Zinc oxide eugenol dental cementA non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components (e.g., rosin/colophony). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in the refrigerator! Protect against exposure to direct sunlight!
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDMG1103600Luxatemp® Automix Solar1103601103602016-09-21
EDMG1103680Luxatemp® Automix Plus1103681103682016-09-21
EDMG1104000Luxatemp® Automix Plus1104001104002016-09-21
EDMG1104010Luxatemp® Automix Plus1104011104012016-09-21
EDMG1104020Luxatemp® Automix Plus1104021104022016-09-21
EDMG1104030Luxatemp® Automix Plus1104031104032016-09-21
EDMG1104040Luxatemp® Automix Plus1104041104042016-09-21
EDMG1104060Luxatemp® Automix Plus1104061104062016-09-21
EDMG1105850Luxatemp® Fluorescence1105851105852016-09-21
EDMG1105860Luxatemp® Fluorescence1105861105862016-09-21
EDMG1105870Luxatemp® Fluorescence1105871105872016-09-21
EDMG1105880Luxatemp® Fluorescence1105881105882016-09-21
EDMG1105890Luxatemp® Fluorescence1105891105892016-09-21
EDMG1107100Luxatemp® Fluorescence1107101107102016-09-21
EDMG1107190Luxatemp® Fluorescence1107191107192016-09-23
EDMG1107220Luxatemp® Fluorescence1107221107222016-09-23
EDMG1107230Luxatemp® Fluorescence1107231107232016-09-23
EDMG2123841LuxaBond - Total Etch2123842123842016-09-23
EDMG2133201TECO2133202133202016-09-22
EDMG2130801Vitique2130802130802016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D161280150AxioIRM 75g powder 40ml liquidAxiodent Inc.EMB2024-09-29
D161280160AxioIRM XS 38g powder 14ml liquidAxiodent Inc.EMB2024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
07898561542205MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542212Fill Canal Liquid (10 mL) 7898561542212 Maquira MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542236MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542250MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546678MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546685MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
00816526020220MASTER-DENTDENTONICS INCEMB2023-10-31
00816526020237MASTER-DENTDENTONICS INCEMB2023-10-31
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15060988910045JJ CAREJack Jack LLCEMB2023-07-15
05021752000723Eugenol B.P. Liquid 150mlASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
05021752000761Zinc Oxide B.P. Powder 150gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
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