FDA.reportPublic FDA data

Oxford Glaze INTRA

Primary DI
EFSM390010
Brand
Oxford Glaze INTRA
Company
First Scientific Dental Materials GmbH
Model
39-001
Device description
Light Cure Varnish for Provisional Crowns & Bridges
Published
2020-11-24
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFSM390010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494121909508info@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
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
EFSM400020Oxford MTA Handmix40-0022020-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29
10386040003896Miracle Mix®Gc America Inc.EMA2022-07-13
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10386040008723GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008730GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008747GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008754GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008761GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008778GC Fuji II LC®Gc America Inc.EMA2022-07-13