FDA.reportPublic FDA data

EXACTA Flow-lc

Primary DI
00815619020161
Brand
EXACTA Flow-lc
Company
EXACTA DENTAL PRODUCTS INC
Model
Shade A1
Catalog number
1-EFA1
Device description
2g syringe of flowable composite for dental restorations.
Published
2018-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815619020161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815619020161008156190201618156190201610815619020161

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016325552
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815619021809EXACTA Temp XtraShade A1NA1-FS2016-08-30
00815619021830EXACTA Temp XtraShade A3.5NA3.5-FS2016-08-30
00815619020420FRESH Bold Impression MaterialCartridge of Bite Registration1-70672016-09-16
00815619020451EXACTA Cement Xtra1-74331-74332016-09-23
00815619020468EXACTA Cement Xtra1-74501-74502016-09-23
00815619020536FRESH Bold Impression MaterialMonophase Cartridge1-74862016-09-23
00815619020550FRESH Bold Impression MaterialMedium Body Cartridge1-74922016-09-23
00815619020567FRESH Bold Impression MaterialHeavy Body Cartridge1-74932016-09-23
00815619020574FRESH Bold Impression MaterialClear Bite Cartridge1-74942016-09-23
00815619020581FRESH Bold Impression MaterialLiquid Putty Cartridge1-74952016-09-23
00815619020598FRESH Bold Impression MaterialMonophase Fast Set Cartridge1-74962016-09-23
00815619020604FRESH Bold Impression MaterialLight Body Fast Set Cartridge1-74972016-09-23
00815619020628FRESH Bold Impression MaterialBlu Max Bite Registration Cartridge1-7701-FS2016-09-23
00815619020871FRESH Bold Impression MaterialHeavy Body Mega Pack7483M2016-09-23
00815619020888FRESH Bold Impression MaterialPutty74852016-09-23
00815619021120FRESH Bold Impression MaterialBite Registration70672016-09-16
00815619021137FRESH Bold Impression MaterialBite Registration Bulk7067BK2016-09-16
00815619021168EXACTA Cement Xtra743374332016-09-16
00815619021175EXACTA Cement Xtra745074502016-09-16
00815619021267FRESH Bold Impression MaterialMonophase74862016-09-16

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