FDA.reportPublic FDA data

MARK3

Primary DI
D79685841
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
8584
Catalog number
8584
Device description
"Mixing Pad 3"" x 3"" 50 Sheets - MARK3®*"
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79685842PackageHIBCC84In Commercial Distribution
D79685841PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing surface, chairside, single-useA pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
845-267-2600info@cargus.com

Regulatory Flags#

DUNS number
096191093
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966125CS1MARK36125CS2021-04-22
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08
00840456223284JMUJMU DENTAL, INCNRD2026-07-08
00840456223291JMUJMU DENTAL, INCNRD2026-07-08
00840456223314JMUJMU DENTAL, INCNRD2026-07-08
D832MTXA15021PlasdentPLASDENT CORPORATIONNRD2026-06-04
D832MTXA15031PlasdentPLASDENT CORPORATIONNRD2026-06-04
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
D678AS50X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
TQ26126171011Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263511Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26126152121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152131Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152151Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152171Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09