FDA.reportPublic FDA data

Select NanoFill

Primary DI
07540208000066
Brand
Select NanoFill
Company
Zendo Direct AG
Model
FIL-RS-A2
Catalog number
FIL-RS-A2
Device description
Low shrink low abrasion light cure nano filled composite - Syringe; Shade A2
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
17540208000063PackageGS11In Commercial Distribution
07540208000066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754020800006317540208000063
07540208000066075402080000667540208000066

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage temperature: max. 77°F (25°C)

Regulatory Flags#

DUNS number
486717338
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540208000165Select SE-Bond LCSEL-ETCH-LC-5mlSEL-ETCH-LC-5ml2017-09-26
07540208000332Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000339Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000391MTA CapsulesZEN-MTA-UNIZEN-MTA-UNI2016-12-15
17540208000407MTA Firm- Normal SetZEN-MTA-FRMNSETZEN-MTA-FRMNSET2017-11-23
17540208000414MTA Firm-Fast SetZEN-MTA-FRMFSTSETZEN-MTA-FRMFSTSET2017-11-23
17540208000421MTA-Flow Fast SetZEN-MTA-FLOFSTZEN-MTA-FLOFST2017-11-23
07540208000011Select Rigid BRRIGBR-LB-SHRIGBR-LB-SH2017-02-21
07540208000059Select NanoFill FIL-RS-A1FIL-RS-A12017-07-05
07540208000073Select NanoFill FIL-RS-A3FIL-RS-A32017-02-21
07540208000219Select Sil Light BodySEL-SIL-LB-SHRS-50SEL-SIL-LB-SHRS-502017-02-21
07540208000226Select Sil Medium BodySEL-SIL-MB-SHRS-PNK5SEL-SIL-MB-SHRS-PNK52017-07-04
07540208000240Select Sil Heavy ViscositySEL-SIL-SHRS-GR50SEL-SIL-SHRS-GR502017-02-21
07540208000356Select Sil Firm PuttySEL-SIL-FR-B400SEL-SIL-FR-B4002017-07-05
07540208000370Select TransbiteSELSIL-TRANS-BSELSIL-TRANS-B2017-11-16
07540208000387Select Calcium Hydroxide Liner LCCAL-LINERCAL-LINER2017-09-26
07540208000448Select Sil Light BodySEL-SIL-LB-SHFS-50SEL-SIL-LB-SHFS-502017-03-07
07540208000455Select Sil Heavy ViscositySEL-SIL-SHFS-GR50SEL-SIL-SHFS-GR502017-03-07
07540208000462Select Sil Medium BodySEL-SIL-MB-SHFS-PNK5SEL-SIL-MB-SHFS-PNK52017-08-09
17540208000131Select NanoFill FIL-RC-A2FIL-RC-A22017-02-21

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