FDA.reportPublic FDA data

Select NanoFill

Primary DI
17540208000063
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
OTC
false
Sterile
false
Single use
false

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)

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486717338
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07540208000066Select NanoFill FIL-RS-A2FIL-RS-A22017-07-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
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