Manufacturer registered with FDA
SPS/Crosstex International
Rush, NY, United States. Lists 17 dental device types with FDA across 3 registered establishments.
- Device types listed
- 17
- Brands and models
- 60
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12134 registrations outside the US
- Establishments
- 3United States
Registered in 12 markets
Where regulators' registries name SPS/Crosstex International as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SPS/Crosstex International | 17 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Crosstex International, Inc. | 25 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | CROSSTEX INTERNATIONAL INCCROSSTEX INTERNATIONAL, INC | 24 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CROSSTEX INTERNATIONAL, INC. | 23 | 2005–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | CROSSTEX INTERNATIONAL INC | 15 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Crosstex International Inc | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Crosstex InternationalCROSSTEX INTERNATIONAL · CROSSTEX INTERNATIONAL, INC · +1 | 11 | 2005–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | CROSSTEX International, Inc. | 11 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Crosstex International | 6 | 2004–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Crosstex International Inc. | 4 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Crosstex International Inc. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Crosstex International,Inc. | 1 | 2016–2016 | 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 SPS/Crosstex International currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Advantage Saliva EjectorComfort Plus Premium Saliva EjectorPREMIUM SALIVA EJECTORSSafe-Flo adaptor M1020ADAPSafe-Flo Saliva Ejector ValveSafe-Flo Saliva EjectorsSafe-Flo valve M1010SUSE, M1030HVSESaliva EjectorSaliva Ejectors | 2007 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Combo-TIpEvacuator Tips (HVE and MaxVac Plus Combo Tip)MaxVac Plus Combo TipSurgical Aspirator Tips | 2012 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | DentaPure DP365 CartridgeDentaPure DP40 Cartridge | 2020 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | AdvantageAdvantage PlusEconobackPatient Barrier ApronPolybackPolyback Contour BibPolycoated headrest coverPolygardPolygard DeluxeProback 5 moreProfessional RegularProfessional ThriftSani-Tab Chain-Free EconobackSani-Tab Chain-Free PolybackUltragard | 2007 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Air/water Syringe SleeveBarrier FilmDigital Sensor SleevesSyringe SleevesTray SleeveX-Ray Sleeves | 2012 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/Water Syringe TipsPatient's Choice Sparkle | 2020 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Lister | TWIST RECIPROCATING D | 2020 |
| Articulation PaperEFH · Class 1 | — | Lister | Horse ShoePrecisely TrueStandard Articulating Paper | 2020 |
| Roll CottonEFN · Class 1 | — | Lister | Cotton Rolls- Advantage PlusCotton Rolls- Premium | 2020 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Sparkle EZ Contra AngleSparkle Prophy AngleTwist Plus | 2020 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Bitewing EaseEdge EaseIt's-A-WrapSensor Slippers | 2020 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Dental Dam, Latex, Powder Free/Low ProteinDental dam, Non-Latex | 2020 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Prophy PasteSparkle FREE Prophy Paste with XylitolSparkle Prophy Paste with Xylitol | 2021 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Lister | Matrix Strips | 2020 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | ZAP Dual Arch Fluoride Gel Trays | 2020 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | Sparkle V Varnish | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Sani-Vac Evacuation System Cleaner | 2020 |
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
SPS/Crosstex International 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: Mrlb Intl., Inc. (2), Medical Products Laboratories, Inc. (1), Pac-Dent International (Suzhou), Ltd. (1), Medidenta Intl., Inc. (1), Strong Marketing (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 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 |
| 8 Sep 1999 | K992893 | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE | Mrlb Intl., Inc. | EIA Operative Dental Unit |
| 7 Sep 1999 | K992868 | DENTAPURE DP40 CARTRIDGE | Mrlb Intl., Inc. | EIA Operative Dental Unit |
| 9 Oct 1997 | K973062 | TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE | Medidenta Intl., Inc. | EFA Dental Belt and/or Gear Driven Handpiece |
| 5 Sep 1985 | K852170 | EZX YELLOW, BLUE OR ORANGE | Strong Marketing | EGZ X-Ray Film Holder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Crosstex InternationalFDA reg. 1319130 | Rush, NY, United States | Manufacturer, Repacker / relabeler, Specification developer |
| CROSSTEX INTERNATIONAL, INC.FDA reg. 3003675658 | LAWRENCEVILLE, GA, United States | Manufacturer |
| CROSSTEX INTERNATIONAL, INC.FDA reg. 3006008984 | SHARON, PA, United States | Manufacturer |
Other names on FDA records
CROSSTEX International, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1319130, 2433773). 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.