Registered with FDA
CARGUS International Inc.
Congers, NY, United States. Lists 36 dental device types with FDA across 1 registered establishment.
- Device types listed
- 36
- Brands and models
- 41
- 510(k) clearances
- 0as applicant
- Markets registered in
- 314 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name CARGUS International Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | CARGUS International Inc. | 36 device types | — | Below |
| Australia | TGA | Manufacturer | Cargus International Inc | 13 | 2016–2021 | Pure Global AI |
| Canada | Health Canada | Registration holder | CARGUS INTERNATIONAL INC. | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What CARGUS International Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2013 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2014 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2017 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2016 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | — | 2014 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2016 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | — | 2016 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | MARK3® Saliva EjectorsMARK3® Surgical Aspirating Tips | 2022 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | — | 2014 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | MARK3® Dispensing Guns | 2016 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | MARK3® Finishing & Polishing | 2022 |
| Pulp TesterEAT · Class 2 | — | Lister | MARK3® Endo Pulp Vitality Refrigerant Spray | 2021 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2016 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | MARK3 Air Water Tips | 2021 |
| Articulation PaperEFH · Class 1 | — | Lister | — | 2016 |
| Roll CottonEFN · Class 1 | — | Lister | MARK3® Cotton Rolls Non Sterile | 2022 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | MARK3® Toothbrushes | 2022 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | MARK3® Bib Holder Autoclavable SiliconMARK3® Bite Wing Tabs | 2022 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | MARK3® White Stones | 2022 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Cargus Bite Registration TraysMARK3® Disposable Impression TraysMARK3® Premium Bite Registration Trays | 2015 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | MARK3® Canister Type Evacuation TrapsMARK3® Disposable Evacuation TrapsMARK3® HVE TIPS | 2021 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | MARK3® Curved Utility SyringeMARK3® Luer Lock Endo Irrigation Syringe | 2022 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | — | 2022 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | MARK3 HP Mixing Tips, Intra-Oral Tips Dynamic Tips & Dispensing Gun.MARK3® Dynamic MixerMARK3® HP Mixing TipsMARK3® Intraoral Mixing Tips | 2014 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | MARK3® Bur Blocks | 2022 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | MARK3 Micro Applicators | 2022 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | — | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | MARK3® Enamel Care Prophy PasteMARK3® Prophy Paste | 2014 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | MARK3 K-FilesMARK3 Rotary Files | 2014 |
| Preformed CrownELZ · Class 1 | — | Lister | MARK3 Polycarbonate CrownsMARK3® Stainless Steel Crowns | 2014 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | — | 2022 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | MARK3® Tofflemire Type Matrix Bands | 2022 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | MARK3® Dental Bibs | 2022 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Cargus Fluoride TraysMARK3® Fluoride Trays | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Cargus Brush TipsMARK3 Infusor Tips | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | MARK3® Bite BlocksMARK3® Disposable Bib HoldersMARK3® Headrest Covers PaperMARK3® Mixing Pads | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
CARGUS International Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Cavex Holland BV (3), Crown Delta Corp. (3), Jedental Co., Inc. (3), Silmet , Ltd. (2), Scientific Pharmaceuticals (2), S & C Polymer GmbH (2), S&C Polymer Silicon- Und Composite Spezialitaeten GmbH (1), Dharma Research, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Apr 2019 | K182778 | LC GLOSSFILL XR | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | EBF Resin Tooth Shade Material |
| 23 Jun 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. | KLE Resin Tooth Bonding Agent |
| 9 Mar 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 4 Dec 2014 | K141092 | MARK3 | Cavex Holland BV | ELW Impression Material |
| 8 Sep 2011 | K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | Silmet , Ltd. | KLE Resin Tooth Bonding Agent |
| 2 Feb 2011 | K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | Silmet , Ltd. | EBF Resin Tooth Shade Material |
| 13 Jan 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | Dmp, Ltd. | ELW Impression Material |
| 9 Dec 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 8 Nov 2007 | K072245 | EMULATE ADVANCED | Cavex Holland BV | ELW Impression Material |
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Jul 2001 | K011419 | CAVEX COLORCHANGE | Cavex Holland BV | ELW Impression Material |
| 16 Feb 2000 | K994012 | TEMPOFIT, MODEL 02693 | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 2 Nov 1999 | K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH | ELW Impression Material |
| 12 Feb 1999 | K982915 | SCI-PHARM DFV VARNISH | Scientific Pharmaceuticals | LBH Cavity Varnish |
| 9 Feb 1999 | K984097 | DC-CORE | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 5 Jun 1998 | K973201 | PROVI CEMENT | S & C Polymer GmbH | EMA Dental Cement |
| 24 Feb 1994 | K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | Jedental Co., Inc. | EMA Dental Cement |
| 26 Jan 1994 | K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER | Jedental Co., Inc. | EMA Dental Cement |
| 7 Jan 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | Crown Delta Corp. | ELW Impression Material |
| 1 Nov 1993 | K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | Jedental Co., Inc. | EMA Dental Cement |
| 21 Jul 1987 | K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 7 Jun 1982 | K821221 | DENTAL IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 24 Nov 1981 | K813091 | FISSURE SEALER & BONDING AGENT | Sci-Pharm, Inc. | EBC Pit and Fissure Sealant and Conditioner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CARGUS INT'L, INC.FDA reg. 2437780 | CONGERS, NY, United States | Repacker / relabeler |
Other names on FDA records
Cargus Int'L, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9033437). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.