Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2437780

FEI Number

3001746544

Entity Name

CARGUS INT'L, INC.

City/State/Country

CONGERS, NY, US

Establishment Address

135 N. RT. 9W, CONGERS, NY 10920, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CARGUS International Inc. (Owner Number: 9033437)

Owner / Operator Contact Address

135 North Route 9W, --, Congers, NY 10920, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MARK3® Bur Blocks MARK3 K-Files MARK3 Rotary Files MARK3® Non Woven Sponges MARK3® Barrier Envelopes MARK3® Luer Lock Endo Irrigation Syringe MARK3® Curved Utility Syringe MARK3® HVE TIPS MARK3® Canister Type Evacuation Traps MARK3® Disposable Evacuation Traps MARK3 Air Water Tips MARK3® Toothbrushes MARK3 Infusor Tips Cargus Brush Tips MARK3® Prophy Paste MARK3® Enamel Care Prophy Paste MARK3® White Stones MARK3 Polycarbonate Crowns MARK3® Stainless Steel Crowns MARK3® Finishing & Polishing MARK3 Indicator Tape MARK3® Root Canal Preparation Cream IntraOral Phosphor Imaging Plates - MARK3® MARK3® Mixing Pads MARK3® Mixing Bowls MARK3® Tofflemire Type Matrix Bands MARK3® Dental Bibs MARK3® Dispensing Guns MARK3® Headrest Covers Paper MARK3® Disposable Bib Holders MARK3® Mixing Pads MARK3® Bite Blocks Cargus MARK3® Endo Pulp Vitality Refrigerant Spray MARK3 Cotton Tip Applicators MARK3® Bib Holder Autoclavable Silicon MARK3® Bite Wing Tabs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2022-07-22
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2022-07-18
EFH	Paper, Articulation	Dental	Class 1	872.6140	2016-07-25
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2014-05-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-04-19
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2022-07-26
ELW	Material, Impression	Dental	Class 2	872.3660	2013-11-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-09
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2022-07-22
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2022-03-15
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2019-01-11
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-01-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-08-29
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2021-04-19
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2021-04-19
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2022-07-26
KXR	Applicator, Resin	Dental	Class 1	872.3140	2021-04-19
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2022-07-25
EJL	Bur, Dental	Dental	Class 1	872.3240	2022-07-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-11-04
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-09-09
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2016-09-09
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2014-02-03
ELW	Material, Impression	Dental	Class 2	872.3660	2020-12-07
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2016-07-08
ELW	Material, Impression	Dental	Class 2	872.3660	2014-01-23
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2022-07-26
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-03-10
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2022-01-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-11-12
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2014-05-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-04-24
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2016-09-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-11-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-11-12
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2016-09-21
ELW	Material, Impression	Dental	Class 2	872.3660	2018-05-11
FME	Gown, Examination	General Hospital	Class 1	880.6265	2022-01-20
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2022-07-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-23
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-04-19
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2021-04-28
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-07
EAM	Screen, Intensifying, Radiographic	Radiology	Class 1	892.1960	2023-08-23
ELW	Material, Impression	Dental	Class 2	872.3660	2014-12-15
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2022-03-15
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2022-07-26
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2022-07-19
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2021-06-08
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2016-07-19
DZM	Needle, Dental	Dental	Class 1	872.4730	2014-10-28
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2014-05-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-12
EAT	Tester, Pulp	Dental	Class 2	872.1720	2021-08-26
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-04-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-01-19
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2021-06-14
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2022-07-19

Official Correspondent

BRYAN MARKIET

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARGUS International Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2437780. Last updated year: 2026. Please use registration number 2437780 when referencing this establishment in official correspondence.