FDA.reportPublic FDA data

NANOCERAM-BRIGHT FLOW

Primary DI
05206569836073
Brand
NANOCERAM-BRIGHT FLOW
Company
DMP DENTAL INDUSTRY S.A.
Model
B1, 2g
Device description
Light curing, flowable, nanohybrid 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
05206569836073PackageGS12In Commercial Distribution
05206569834079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05206569836073052065698360735206569836073
05206569834079052065698340795206569834079

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08809518345663One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
08809518345670One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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