FDA.reportPublic FDA data

breCAM.BioHPP

Primary DI
EBRE540021210
Brand
breCAM.BioHPP
Company
bredent GmbH & Co. KG
Model
54002121
Catalog number
54002121
Device description
breCAM.BioHPP Ø 98 x 20mm AG dentin-shade 2 1 Piece
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRE540021219PackageHIBCC1Not in Commercial Distribution
EBRE540021210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry
Special Storage Condition, Specify00keep out of sunlight

Contacts#

Phone, Email table
PhoneEmail
+4907309872451info@bredent.com

Regulatory Flags#

DUNS number
341086190
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBRE540033990breCAM.HIPC540033992026-05-07
EBRE540034010breCAM.HIPC540034012026-05-07
EBRE540034060breCAM.HIPC540034062026-05-07
EBRE540021110breCAM.BioHPP54002111540021112016-09-20
EBRE580012660Qu-resin dentin58001266580012662023-09-07
EBREVLCOLBLACK0visio.lign color BlackVLCOLBLACKVLCOLBLACK2025-03-10
EBREVLCOLBLUE0visio.lign color BlueVLCOLBLUEVLCOLBLUE2025-03-10
EBREVLCOLBODYA0visio.lign color Body AVLCOLBODYAVLCOLBODYA2025-03-10
EBREVLCOLBODYB0visio.lign color Body BVLCOLBODYBVLCOLBODYB2025-03-10
EBREVLCOLBODYC0visio.lign color Body CVLCOLBODYCVLCOLBODYC2025-03-10
EBREVLCOLBODYD0visio.lign color Body DVLCOLBODYDVLCOLBODYD2025-03-10
EBREVLCOLBROWN0visio.lign color BrownVLCOLBROWNVLCOLBROWN2025-03-10
EBREVLCOLCREME0visio.lign color CremeVLCOLCREMEVLCOLCREME2025-03-10
EBREVLCOLGLIGHT0visio.lign color Gum LightVLCOLGLIGHTVLCOLGLIGHT2025-03-10
EBREVLCOLGPINK0visio.lign color Gum PinkVLCOLGPINKVLCOLGPINK2025-03-10
EBREVLCOLGRED0visio.lign color Gum RedVLCOLGREDVLCOLGRED2025-03-10
EBREVLCOLGREYBL0visio.lign color Grey-BlueVLCOLGREYBLVLCOLGREYBL2025-03-10
EBREVLCOLOLIVE0visio.lign color OliveVLCOLOLIVEVLCOLOLIVE2025-03-10
EBREVLCOLORANGE0visio.lign color OrangeVLCOLORANGEVLCOLORANGE2025-03-10
EBREVLCOLROSE0visio.lign color RoseVLCOLROSEVLCOLROSE2025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29