Manufacturer registered with FDA
Pascal International
Bellevue, WA, United States. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 53
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1069 registrations outside the US
- Establishments
- 1United States
Registered in 10 markets
Where regulators' registries name Pascal 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 | Pascal International | 13 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Pascal International, Inc. | 21 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | PASCAL INTERNATIONAL INC | 17 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PASCAL INTERNATIONAL, INC.Pascal International, Inc. | 14 | 1999–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PASCAL INTERNATIONAL, INC.Pascal International, Inc. | 6 | 2010–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PASCAL INTERNATIONAL, INC. | 4 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | PASCAL International , IncPascal International, Inc. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PASCAL INTERNATIONAL, INC. | 2 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Pascal International Inc | 1 | 2023–2023 | Pure Global AI |
| China | NMPA | Registration holder | 帕斯可Pascal International, Inc. | 1 | — | 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 Pascal 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | RAFORMER | 1992 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Retrax System Mirror | 2021 |
| Articulation PaperEFH · Class 1 | — | Maker | HYDENTHYDENT STICKSOCCLUDE | 1992 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Lister | NanoBytePROMARK FORCEPSRetrax Tweezer | 1992 |
| Roll CottonEFN · Class 1 | — | Lister | IsolatorMini Isolator | 2019 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Contra AngleProphy Angle | 1983 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | ORATIP | 1992 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Black Retrax System R-101Black Retrax System R-11Black Retrax System R-50Black Retrax System R-55Guyer 7A Retraction Packing InstrMicroGrip Pro Multi-use InstrumentPick PackPick Pack FortePT-55 Retraction Packing InstrumentR-101 Retraction Packing Instrument 9 moreR-11 Retraction Packing InstrumentR-50 Retraction Packing InstrumentR-55 Retraction Packing InstrumentR-55A Retraction Packing InstrumentR-EX Retraction ExplorerRetrax Cord CutterRetrax MirrorRetrax System Locking TweezerRetrax System Tweezer | 2001 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Get Sculpted Wax Carving Set | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | BK ProbeC-IPC Composite Placing InstrumentC-IPC/Off Angle Composite PlacingC-Plugger Composite Placing InstrumGet PackedKois KR SeriesR-101 PACKING INSTRUMENTR-11R-11 PACKING INSTRUMENTR-55 2 more, R-50101 | 1992 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | RADENT PROPHY PASTERadent Prophy Paste - Non Fluoride | 2004 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Juciy TrayJuicy Tray Animal PalsPDP Foam Fluoride Tray | 2008 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | FluorilaqFluorilaq SqueezeFluorilaq Unit Dose | 2007 |
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
Pascal 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: Pascal Co., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 May 2003 | K030488 | FLUORILAQ | Pascal Co., Inc. | LBH Cavity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Pascal International, Inc.FDA reg. 3011632 | Bellevue, WA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 3011632). 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.