FDA.reportPublic FDA data

NANOCERAM-BRIGHT

Primary DI
05206569884074
Brand
NANOCERAM-BRIGHT
Company
DMP DENTAL INDUSTRY S.A.
Model
B1, 4g
Device description
Light curing, nanohybrid universal composite. Radiopaque resin-based dental restorative material for anterior and 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

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
05206569884074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05206569884074052065698840745206569884074

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
Lot or batch
true
Expiration date on label
true

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
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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