FDA.reportPublic FDA data

PIT & FISSURE SEALANT

Primary DI
05206569864182
Brand
PIT & FISSURE SEALANT
Company
DMP DENTAL INDUSTRY S.A.
Model
Opaque, 2g
Device description
Light curing, fluoride releasing sealant. Radiopaque, resin-based dental material for the sealing of pits and fissures.
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
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05206569866186PackageGS12In Commercial Distribution
05206569864182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05206569866186052065698661865206569866186
05206569864182052065698641825206569864182

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
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

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
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
05206569884074NANOCERAM-BRIGHTB1, 4g2016-09-24

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