FDA.reportPublic FDA data

TempoCemID

Primary DI
EDMG2132008
Brand
TempoCemID
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
213200
Catalog number
213200
Device description
Temporary cement smartmix system. Invisible under restorations, yet detectable for excess removal. Content: 1 syringe @ 5ml, Accessories.
Published
2017-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160443000TempoCem ClearDmg USA, Inc.2016-09-30EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2132001PackageHIBCC1In Commercial Distribution
EDMG2132008PackageHIBCC12In Commercial Distribution
EDMG2132000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature. Protect against exposure to direct sunlight!

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
320744915
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118536NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
08809911118543NuSmile NuCemNUSMILE, LTD.EMA2026-04-08
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14