FDA.report

MARK3

Primary DI
D7961683
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
1683
Device description
Enamel Care 5% Sodium Fluoride Varnish w/ Calcium & Phosphate Mint 50/bx. - MARK3
Published
2021-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LBHVarnish, Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79616830PrimaryHIBCC0
D7961683Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
50
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D7714227200BG0Dental CityICP, INC.LBH2026-03-24
D7714227200M0Dental CityICP, INC.LBH2026-03-24
D7714227200ML0Dental CityICP, INC.LBH2026-03-24
D771422750ML0Dental CityICP, INC.LBH2026-03-24
G402DENTOCLUDE1Dentoclude FCUMBERLAND BIOTHERAPEUTICS LLCLBH2026-03-19
09336472038212RIVA STARSDI LIMITEDLBH2026-02-16
09336472038366RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038403RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038441RIVA STARSDI LIMITEDLBH2026-02-16
00883205044068EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044075EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044082EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044099EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044105EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044112EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044129EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044136EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00858290006970FluoriMax 2.5% NaF demo pack ELEVATE ORAL CARE, LLCLBH2026-01-28
00827854027126Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00827854027577Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00883205044143EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044150EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044167EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044174EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00850006606719Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00850006606726Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00883205033000EnamelastULTRADENT PRODUCTS, INC.LBH2025-08-23
00883205032829ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
00883205032843ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
07615208545753Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10