FDA.reportPublic FDA data

MARK3

Primary DI
D79680951
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
8095
Catalog number
8095
Device description
Disposable Micro Applicators Fine Assorted Colors (Yellow, Pink) 400/bx. - MARK3®
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79680951PrimaryHIBCC0
D79680952Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Regulatory Flags#

DUNS number
096191093
Device count
400
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
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03