Manufacturer registered with FDA
The Belport Company, Inc. DBA Gingi-Pak
Camarillo, CA, United States. Lists 15 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 46
- 510(k) clearances
- 22026–2026
- Markets registered in
- 646 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name The Belport Company, Inc. DBA Gingi-Pak 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 | The Belport Company, Inc. DBA Gingi-Pak | 2 clearances | 2026–2026 | Below |
| Canada | Health Canada | Registration holder | THE BELPORT COMPANY, INC. DBA GINGI-PAK | 30 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | The Belport Company Inc dba Gingi-Pak | 10 | 2024–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | The Belport Company, Inc. DBA Gingi-Pak | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | The Belport Company, Inc. DBA Gingi-Pak | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | The Belport Company Inc. dba Gingi-Pak | 1 | 1998–1998 | 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 The Belport Company, Inc. DBA Gingi-Pak currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | — | 2019 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Ceramic Hybrid ResinOptiFlow IIRodin Titan 3d Resin23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle23986, Rodin Titan, Shade B1, 1.2kg/Bottle23987, Rodin Titan, Shade A1, 1.2kg/Bottle23988, Rodin Titan, Shade A2, 1.2kg/Bottle23989, Rodin Titan, Shade A3, 1.2kg/Bottle23990, Rodin Titan, Shade C2, 1.2kg/Bottle23991, Rodin Titan, Shade 0M3, 600g/Bottle 14 more23992, Rodin Titan, Shade B1, 600g/Bottle23993, Rodin Titan, Shade A1, 600g/Bottle23994, Rodin Titan, Shade A2, 600g/Bottle23995, Rodin Titan, Shade A3, 600g/Bottle23996, Rodin Titan, Shade C2, 600g/Bottle23997, Rodin Titan, Shade 0M3, 300g/Bottle23998, Rodin Titan, Shade B1, 300g/Bottle23999, Rodin Titan, Shade A1, 300g/Bottle24000, Rodin Titan, Shade A2, 300g/Bottle24001, Rodin Titan, Shade A3, 300g/Bottle24002, Rodin Titan, Shade C2, 300g/Bottle24003, Rodin Titan, Shade 0M1, 1.2kg/Bottle24004, Rodin Titan, Shade 0M1, 600g/Bottle24005, Rodin Titan, Shade 0M1, 300g/Bottle | 2021 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | — | 2017 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | — | 1994 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | — | 2019 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 1992 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | — | 2019 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Rodin Titan 3d Resin23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle23986, Rodin Titan, Shade B1, 1.2kg/Bottle23987, Rodin Titan, Shade A1, 1.2kg/Bottle23988, Rodin Titan, Shade A2, 1.2kg/Bottle23989, Rodin Titan, Shade A3, 1.2kg/Bottle23990, Rodin Titan, Shade C2, 1.2kg/Bottle23991, Rodin Titan, Shade 0M3, 600g/Bottle23992, Rodin Titan, Shade B1, 600g/Bottle23993, Rodin Titan, Shade A1, 600g/Bottle 12 more23994, Rodin Titan, Shade A2, 600g/Bottle23995, Rodin Titan, Shade A3, 600g/Bottle23996, Rodin Titan, Shade C2, 600g/Bottle23997, Rodin Titan, Shade 0M3, 300g/Bottle23998, Rodin Titan, Shade B1, 300g/Bottle23999, Rodin Titan, Shade A1, 300g/Bottle24000, Rodin Titan, Shade A2, 300g/Bottle24001, Rodin Titan, Shade A3, 300g/Bottle24002, Rodin Titan, Shade C2, 300g/Bottle24003, Rodin Titan, Shade 0M1, 1.2kg/Bottle24004, Rodin Titan, Shade 0M1, 600g/Bottle24005, Rodin Titan, Shade 0M1, 300g/Bottle | 2025 |
| Shellac Base PlateEEA · Class 1 | — | Maker | — | 2019 |
| Roll CottonEFN · Class 1 | — | Lister | — | 1992 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 1992 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 1992 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | — | 2019 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names The Belport Company, Inc. DBA Gingi-Pak as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Oct 2026 | K262775 | AquaVance Clear Fluoride Treatment | LBH Cavity Varnish |
| 7 Aug 2026 | K261937 | PacTemp Automix NE | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Pac-Dent Inc. (1).
Also lists devices cleared under other names
The Belport Company, Inc. DBA Gingi-Pak 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: Matech, Inc. (6), Belport Company, Inc., Gingi-Pak (2), Belport Co., Inc. (2), Pac-Dent Inc. (1), Pac-Dent International, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Jun 2024 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI Rebasing Repairing Relining Denture Resin |
| 26 Jul 2021 | K210412 | Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent Inc. | EBF Resin Tooth Shade Material |
| 2 Sep 2020 | K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | KLE Resin Tooth Bonding Agent |
| 13 Aug 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Pac-Dent International, Inc. | EBF Resin Tooth Shade Material |
| 15 Feb 2001 | K010069 | DURABOND NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | EJH Base Metal Alloy |
| 13 Dec 1999 | K993572 | CERADIUM V NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | EJH Base Metal Alloy |
| 19 Nov 1999 | K992881 | HI BOND NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | EJH Base Metal Alloy |
| 22 Sep 1999 | K992705 | CERADIUM NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | EJH Base Metal Alloy |
| 12 Feb 1998 | K974894 | KROMATICA COLOR CHANGING ALGINATE | Matech, Inc. | ELW Impression Material |
| 21 Jan 1994 | K925746 | REPLICA | Matech, Inc. | ELW Impression Material |
| 22 Feb 1982 | K820061 | REVERSIBLE HYDROCOLLOID IMPRESSION MAT | Belport Co., Inc. | ELW Impression Material |
| 8 Sep 1981 | K812120 | GINGI-PLAIN CORDS & BRAIDS | Belport Co., Inc. | JES Dental Floss |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| The Belport Company, Inc DBA Gingi-PakFDA reg. 2014676 | CAMARILLO, CA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2014676). 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.