FDA.reportPublic FDA data

Oxford Temp A1

Primary DI
EFSM30001A10
Brand
Oxford Temp A1
Company
First Scientific Dental Materials GmbH
Model
30-001A1
Device description
Temporary Crown & Bridge Material 10:1
Published
2020-09-06
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
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFSM30001A10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

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
+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
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
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28