FDA.reportPublic FDA data

Kera®Soft-Disc 98,0 x 20 mm

Primary DI
EDWA130412201
Brand
Kera®Soft-Disc 98,0 x 20 mm
Company
Eisenbacher Dentalwaren ED GmbH
Model
13041220
Device description
Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 20 mm
Published
2023-06-23
Public version status
New
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
EDWA130412201PrimaryHIBCC0

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
344231006
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDWAT100452131Kera Ti5-Disc 98,5 x 13,5 mmT100452132023-10-04
EDWA110512161Kera®starSplint Bio110512162023-06-23
EDWA130412121Kera®Soft-Disc 98,0 x 12 mm130412122023-06-23
EDWA130412141Kera®Soft-Disc 98,0 x 14 mm130412142023-06-23
EDWA130412161Kera®Soft-Disc 98,0 x 16 mm130412162023-06-23
EDWA131412181Kera®Soft-Disc 98,0 x 18 mm130412182023-06-23
EDWA1004000PK1Kera S-Powder1004000PK2020-07-17
EDWAT100451081Kera Ti5-Disc 99,5 x 8 mmT100451082020-02-06
EDWAT100451101Kera Ti5-Disc 99,5 x 10 mmT100451102020-02-06
EDWAT100451121Kera Ti5-Disc 99,5 x 12 mmT100451122020-02-06
EDWAT100451141Kera Ti5-Disc 99,5 x 14 mmT100451142020-02-06
EDWAT100451151Kera Ti5-Disc 99,5 x 15 mmT100451152020-02-06
EDWAT100451161Kera Ti5-Disc 99,5 x 16 mmT100451162020-02-06
EDWAT100451181Kera Ti5-Disc 99,5 x 18 mmT100451182020-02-06
EDWAT100451201Kera Ti5-Disc 99,5 x 20 mmT100451202020-02-06
EDWAT100451251Kera Ti5-Disc 99,5 x 25 mmT100451252020-02-06
EDWAT100451271Kera Ti5-Disc 99,5 x 27 mmT100451272020-02-06
EDWAT100452081Kera Ti5-Disc 98,5 x 8 mmT100452082020-02-06
EDWAT100452101Kera Ti5-Disc 98,5 x 10 mmT100452102020-02-06
EDWAT100452121Kera Ti5-Disc 98,5 x 12 mmT100452122020-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
07630031703170Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703187Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703194Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703200Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703217Base metal alloyInstitut Straumann AGEJH2019-08-31
07630031703224Base metal alloyInstitut Straumann AGEJH2019-08-31