FDA.reportPublic FDA data

System Soft-Blank 98,3 x 8 mm

Primary DI
EADT20081
Brand
System Soft-Blank 98,3 x 8 mm
Company
Adentatec GmbH Competence in Dental
Model
2008
Device description
Cobalt based dental milling alloy, type 4, Dimension: 98, 3 x 8 mm
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EJHAlloy, Metal, Base

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EADT20081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting non-noble alloyA material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537287336
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EADT6008T1System Ti5-Blank 99,5 x 8 mm6008-T2020-02-06
EADT6010T1System Ti5-Blank 99,5 x 10 mm6010-T2020-02-06
EADT6012T1System Ti5-Blank 99,5 x 12 mm6012-T2020-02-06
EADT6014T1System Ti5-Blank 99,5 x 14 mm6014-T2020-02-06
EADT6015T1System Ti5-Blank 99,5 x 15 mm6015-T2020-02-06
EADT6016T1System Ti5-Blank 99,5 x 16 mm6016-T2020-02-06
EADT6018T1System Ti5-Blank 99,5 x 18 mm6018-T2020-02-06
EADT6020T1System Ti5-Blank 99,5 x 20 mm6020-T2020-02-06
EADT6025T1System Ti5-Blank 99,5 x 25 mm6025-T2020-02-06
EADT6027T1System Ti5-Blank 99,5 x 27 mm6027-T2020-02-06
EADT7008T1System Ti5-Blank 98,5 x 8 mm7008-T2020-02-06
EADT7010T1System Ti5-Blank 98,5 x 10 mm7010-T2020-02-06
EADT7012T1System Ti5-Blank 98,5 x 12 mm7012-T2020-02-06
EADT7014T1System Ti5-Blank 98,5 x 14 mm7014-T2020-02-06
EADT7015T1System Ti5-Blank 98,5 x 15 mm7015-T2020-02-06
EADT7016T1System Ti5-Blank 98,5 x 16 mm7016-T2020-02-06
EADT7018T1System Ti5-Blank 98,5 x 18 mm7018-T2020-02-06
EADT7020T1System Ti5-Blank 98,5 x 20 mm7020-T2020-02-06
EADT7022T1System Ti5-Blank 98,5 x 22 mm7022-T2020-02-06
EADT7025T1System Ti5-Blank 98,5 x 25 mm7025-T2020-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760357974917Prime V Disc 98.5 x13.5 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974924Prime V Disc 98.5 x12 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974931Prime V Disc 98.5 x16 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974948Prime V Disc 98.5 x18 mmBERNARD CERVOS SOCIETEEJH2026-06-09
03760357974955Prime V Disc 98.5 x20 mmBERNARD CERVOS SOCIETEEJH2026-06-09
EYET96300010SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET96390120Solibond N Alloy Blank (98,5), 12mm, 1 diskYeti Dentalprodukte GmbHEJH2026-05-11
EYET96900010SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-05-11
EYET6050060M0Bite regist. Metal foil wax, brown,SampleYeti Dentalprodukte GmbHEJH2026-04-16
EYET9600100A0Solidur CoCr Partial Denture Alloys 100gYeti Dentalprodukte GmbHEJH2026-04-16
EYET9630001M0Sample SOLIBOND N, Ni.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9690001M0Sample SOLIBOND C plus, Co.Cr. Alloy 18g.Yeti Dentalprodukte GmbHEJH2026-04-16
EYET9600001M0Sample SOLIDUR CoCr Alloy 30gYeti Dentalprodukte GmbHEJH2026-04-13
06975902950026CoCr Alloy PowderRiton 3D Technology Co., LtdEJH2023-06-04
EBGO505321Mediloy RPDBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2023-05-12
08050612201229Magnum Vip-AMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202103Magnum Saldatura BMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202110Magnum Saldatura CoMESA DI SALA GIACOMO & C. SNCEJH2020-11-11
08050612202455Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
08050612202462Magnum HyperoneMESA DI SALA GIACOMO & C. SNCEJH2020-06-18
J011102403890remanium®DENTAURUM GmbH & Co.KGEJH2019-11-20
07630031703088Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703095Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703101Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703118Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703125Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703132Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703149Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703156Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703163Base metal alloyInstitut Straumann AGEJH2019-08-31