FDA.reportPublic FDA data

BRIGHT LIGHT FLOW

Primary DI
05206569876048
Brand
BRIGHT LIGHT FLOW
Company
DMP DENTAL INDUSTRY S.A.
Model
A2 Opaque, 2g
Device description
Light curing, flowable, microhybrid composite. Radiopaque, resin-based dental restorative material for anterior and limited posterior restorations.
Published
2016-09-24
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

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
05206569876048PackageGS12In Commercial Distribution
05206569000726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05206569876048052065698760485206569876048
05206569000726052065690007265206569000726

GMDN Terms#

Term, Definition table
TermDefinition
Light-cured dental restorative composite resinA dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+302299023041info@dmpdental.com

Regulatory Flags#

DUNS number
728534814
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
05206569730029ETCHING GEL10ml2020-07-22
05206569730043ETCHING GEL50ml2020-07-22
05206569730012Etching Gel3ml2017-09-01
05206569001822SINGLE BONDING1ml2020-07-22
05206569760019SINGLE BONDING3ml2020-07-22
05206569760026SINGLE BONDING5ml2020-07-22
05206569000719BRIGHT LIGHT FLOWA3, 2g2016-09-24
05206569000740BRIGHT LIGHT FLOWB1, 2g2016-09-24
05206569834024NANOCERAM-BRIGHT FLOWA2, 2g2016-09-24
05206569834086NANOCERAM-BRIGHT FLOWB2, 2g2016-09-24
05206569834116NANOCERAM-BRIGHT FLOWC1, 2g2016-09-24
05206569834154NANOCERAM-BRIGHT FLOWD2, 2g2016-09-24
05206569864182PIT & FISSURE SEALANT Opaque, 2g2016-09-24
05206569824018BRIGHT POSTERIOR A1, 4g2016-09-24
05206569825015BRIGHT POSTERIOR A1, 0.25g x 201801225012016-09-24
05206569825022BRIGHT POSTERIOR A2, 0.25g x 201801225022016-09-24
05206569825039BRIGHT POSTERIOR A3, 0.25g x 201801225032016-09-24
05206569852011BRIGHT FLOW COREUniversal, 5ml2016-09-24
05206569884012NANOCERAM-BRIGHTA1, 4g2016-09-24
05206569884067NANOCERAM-BRIGHTA4, 4g2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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