FDA.reportPublic FDA data

Oxford GI Resin CEM UF Handmix

Primary DI
EFSM510100
Brand
Oxford GI Resin CEM UF Handmix
Company
First Scientific Dental Materials GmbH
Model
51-010
Device description
Light Cure Ultra Fine Resin Modified Glass Ionomer Cement for Luting
Published
2020-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFSM510100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile 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 an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4904121909508info@oxford-scientific.de

Regulatory Flags#

DUNS number
341553292
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFSM320010Oxford Temp CEM Flexi-Trans32-0012020-11-24
EFSM320020Oxford Temp CEM Universal32-0022020-09-06
EFSM210050Oxford Universal Bond21-0052020-11-24
EFSM200010Oxford Bond TE Mono20-0012020-09-06
EFSM210010Oxford Bond SE Mono21-0012020-09-06
EFSM210020Oxford Bond SE Dual21-0022020-09-06
EFSM510140Oxford GI Resin PRIME VLC51-0142020-09-06
EFSM110040Oxford SpheriChrome Flow11-0042022-05-29
EFSM100070Oxford SpheriChrome10-0072022-03-06
EFSM100100Oxford SpheriBlokk10-0102022-03-06
EFSM30001A30Oxford Temp A330-001A32020-11-24
EFSM390010Oxford Glaze INTRA39-0012020-11-24
EFSM30001A10Oxford Temp A130-001A12020-09-06
EFSM30001A20Oxford Temp A230-001A22020-09-06
EFSM12013A20Oxford Zircore NANO A212-013A22020-11-24
EFSM150020Oxford Root FILL System15-0022020-11-24
EFSM12001BLUE0Oxford Zircore NANO Blue12-001BLUE2020-11-24
EFSM12005A30Oxford Flo CEM A312-005A32020-11-24
E12013A2Oxford Zircore NANO A212-013A22020-11-24
E15002Oxford Root FILL System15-0022020-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
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