FDA.report

MARK3

Primary DI
D7964542
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
4542CS
Device description
Pit & Fissure Sealant Case
Published
2021-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications

CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79645420PrimaryHIBCC0
D7964542CS1PrimaryHIBCC0
D7964542Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. 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

TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
100
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
true
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 DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
D7969003MARK390032025-03-06
D7969001MARK390012025-02-28
00850014374532MARK3855-016XC855-016XC2024-07-24
00850014374549MARK3848-018XC848-018XC2024-07-24
00850014374556MARK3652S-018XC652S-018XC2024-07-24
00850014374563MARK3655S-018XC655S-018XC2024-07-24
00850014374570MARK3855-018C855-018C2024-07-24
00850014374587MARK3652S-017XC652S-017XC2024-07-24
D79616501MARK3165016502024-07-22
D79616521MARK3165216522024-07-22
D79616541MARK3165416542024-07-22
D79614260MARK3142614262023-11-15
D7961426X0MARK31426X1426X2023-11-15
D79614300MARK3143014302023-11-15
D79614320MARK3143214322023-11-15
D79614330MARK3143314332023-11-15
D79619112MARK3191119112023-11-09
D79619122MARK3191219122023-11-09

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Primary DIBrandCompanyProduct codePublished
07290115053340Quick SealB.J.M. LABORATORIES LTDEBC2026-03-13
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00810118106477NuSmile NuNamel Pit & Fissure SealantNUSMILE, LTD.EBC2025-07-24
00810118106484NuSmile NuNamel Pit & Fissure SealantNUSMILE, LTD.EBC2025-07-24
09336472011352CONSEALSDI LIMITEDEBC2025-01-08
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09336472011420CONSEALSDI LIMITEDEBC2025-01-08
09336472016326RIVA COATSDI LIMITEDEBC2025-01-08
09336472016760RIVA CONDITIONERSDI LIMITEDEBC2025-01-08
09336472017248RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017309RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017316RIVA PROTECTSDI LIMITEDEBC2025-01-08
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09336472017378RIVA PROTECTSDI LIMITEDEBC2025-01-08
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