FDA Registration
Active
🇺🇸 United States
CARGUS INT'L, INC.
Reg #: 2437780
·
FEI: 3001746544
·
Expires 2026
Products
54
Proprietary Names
49
Establishment Types
1
Classifications
54
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Registration Details
- Registration Name
- CARGUS INT'L, INC.
- Registration Number
- 2437780
- FEI Number
- 3001746544
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 135 N. RT. 9W
- City
- CONGERS
- State
- NY
- ZIP
- 10920
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011419
Owner / Operator
- Firm Name
- CARGUS International Inc.
- Operator Number
- 9033437
- Address
- 135 North Route 9W, --
- City
- Congers
- State
- NY
- Postal Code
- 10920
- Country
- US
- Correspondent
- BRYAN - MARKIET
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2022-07-22 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2022-07-18 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2016-07-25 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2014-05-27 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-04-19 |
| Barrier, Control Panel, X-Ray, Movable | IWX | Class 1 | Radiology | No | 2022-07-26 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-06-09 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2022-07-22 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2022-03-15 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2019-01-11 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2019-01-11 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-08-29 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2021-04-19 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2021-04-19 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2022-07-26 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2021-04-19 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2022-07-25 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2022-07-18 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2020-11-04 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2016-09-09 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2016-09-09 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2014-02-03 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2016-07-08 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2022-07-26 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2022-01-11 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2014-05-27 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2016-09-09 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2016-09-21 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2022-01-20 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2022-07-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-23 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2023-11-07 |
| Screen, Intensifying, Radiographic | EAM | Class 1 | Radiology | No | 2023-08-23 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2022-03-15 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2022-07-26 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2022-07-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2016-07-19 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2014-10-28 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2014-05-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2021-08-26 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2021-04-19 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2022-07-19 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2022-07-22 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2014-12-26 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2015-10-05 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2015-10-05 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-07-29 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2022-03-25 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-11-07 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-11-07 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2022-07-19 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2022-05-18 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-08-23 |
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® Bite Blocks
Cargus
MARK3® Endo Pulp Vitality Refrigerant Spray
MARK3 Cotton Tip Applicators
MARK3® Bib Holder Autoclavable Silicon
MARK3® Bite Wing Tabs
MARK3® Saliva Ejectors
MARK3® Surgical Aspirating Tips
MARK3 HP Mixing Tips, Intra-Oral Tips Dynamic Tips & Dispensing Gun.
MARK3® Dynamic Mixer
MARK3® HP Mixing Tips
MARK3® Intraoral Mixing Tips
MARK3® Fluoride Trays
Cargus Fluoride Trays
MARK3® Premium Bite Registration Trays
Cargus Bite Registration Trays
MARK3® Disposable Impression Trays
MARK3 Micro Applicators
MARK3® Cotton Rolls Non Sterile
Establishment Types
Repack or Relabel Medical Device