Data / Medical devices / United States / Cargus Int'l, Inc.
Cargus Int'l, Inc.: FDA-registered device maker in Congers, NY, United States, 36 510(k) clearances
Cargus Int'l, Inc. is registered with the FDA (registration 2437780) in Congers, NY, United States. It lists 54 device types. The FDA files 36 510(k) clearances under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2437780
- FEI number
- 3001746544
- Address
- 135 N. RT. 9W, Congers, NY, United States, 10920
- Owner or operator
- CARGUS International Inc. (9033437)
- Roles
- Repackager or relabeler
- First device listed
- November 18, 2013
- Registered through
- 2026
- Brand names listed
- Cargus, Cargus Bite Registration Trays, Cargus Brush Tips, Cargus Fluoride Trays, IntraOral Phosphor Imaging Plates - MARK3®, MARK3 Air Water Tips, MARK3 Cotton Tip Applicators, MARK3 HP Mixing Tips, Intra-Oral Tips Dynamic Tips & Dispensing Gun. and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2022 | K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | FXX | Substantially Equivalent | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | accessdata.fda.gov |
| July 6, 2020 | K200330 | RC-Prime Root Canal Preparation Cream | KJJ | Substantially Equivalent | Pac-Dent, Inc. | accessdata.fda.gov |
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 22, 2019 | K182778 | LC GLOSSFILL XR | EBF | Substantially Equivalent | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | accessdata.fda.gov |
| February 22, 2018 | K171823 | U&U Indicator tape and strip | JOJ | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| September 8, 2017 | K171667 | Powder Free Nitrile Examination Glove | LZA | Substantially Equivalent | Professional Latex Sdn Bhd | accessdata.fda.gov |
| April 28, 2017 | K162258 | Self Sealing Sterilization Pouches | FRG | Substantially Equivalent | Tianchang Jiarui Packaging Material Co., Ltd. | accessdata.fda.gov |
| March 3, 2016 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | PEM | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| February 1, 2016 | K153528 | PacEndo EDTA | KJJ | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| September 9, 2015 | K143637 | U&U Sterilization Pouch and Roll | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| June 23, 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | KLE | Substantially Equivalent | Dharma Research, Inc. | accessdata.fda.gov |
| March 9, 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT | EBC | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| December 4, 2014 | K141092 | MARK3 | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| September 8, 2011 | K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | KLE | Substantially Equivalent | Silmet , Ltd. | accessdata.fda.gov |
| February 2, 2011 | K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | EBF | Substantially Equivalent | Silmet , Ltd. | accessdata.fda.gov |
| January 13, 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | ELW | Substantially Equivalent | Dmp, Ltd. | accessdata.fda.gov |
| December 9, 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | EGS | Substantially Equivalent | Premium Plus International Limited | accessdata.fda.gov |
| July 6, 2010 | K101736 | NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED | FLL | Substantially Equivalent | Shenzhen Everbest Machinery Industry Co., Ltd. | accessdata.fda.gov |
| November 8, 2007 | K072245 | EMULATE ADVANCED | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| February 4, 2004 | K040098 | VARNISHAMERICA | LBH | Substantially Equivalent | Medical Products Laboratories, Inc. | accessdata.fda.gov |
| April 14, 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Pac-Dent International (Suzhou), Ltd. | accessdata.fda.gov |
| July 16, 2001 | K011419 | CAVEX COLORCHANGE | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| February 16, 2000 | K994012 | TEMPOFIT, MODEL 02693 | EBG | Substantially Equivalent | Detax GmbH & Co. KG | accessdata.fda.gov |
| November 2, 1999 | K992001 | TRAY-LINK | ELW | Substantially Equivalent | Silicon-Und Composite Spezialitaten GmbH | accessdata.fda.gov |
| July 14, 1999 | K991616 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 12, 1999 | K982915 | SCI-PHARM DFV VARNISH | LBH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| February 9, 1999 | K984097 | DC-CORE | EBF | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| June 5, 1998 | K973201 | PROVI CEMENT | EMA | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| February 24, 1994 | K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | EMA | Substantially Equivalent | Jedental Co., Inc. | accessdata.fda.gov |
| January 26, 1994 | K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER | EMA | Substantially Equivalent | Jedental Co., Inc. | accessdata.fda.gov |
| January 7, 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| November 1, 1993 | K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | EMA | Substantially Equivalent | Jedental Co., Inc. | accessdata.fda.gov |
| July 21, 1987 | K872569 | TEMREX ETCHING GEL | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| June 7, 1982 | K821221 | DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| November 24, 1981 | K813091 | FISSURE SEALER & BONDING AGENT | EBC | Substantially Equivalent | Sci-Pharm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixer, Cement, For Clinical Use
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- All makers of Material, Impression
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- All makers of Applicator, Absorbent Tipped, Non-Sterile
Updated May 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.