Manufacturer registered with FDA
DeRoyal Industries Inc
Powell, TN, United States. Lists 7 dental device types with FDA across 8 registered establishments.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 15952 registrations outside the US
- Establishments
- 8Dominican Republic, Guatemala, United States
Registered in 15 markets
Where regulators' registries name DeRoyal Industries Inc 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 | DeRoyal Industries Inc | 7 device types | — | Below |
| Canada | Health Canada | Registration holder | DEROYAL INDUSTRIES INC. | 335 | 1999–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DeRoyal Industries, Inc. | 256 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DeRoyal Industries, Inc. | 141 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DEROYAL INDUSTRIES INC.DEROYAL INDUSTRIES, INC. · DEROYAL INDUSTRIES INC · +2 | 65 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DeRoyal Industries, Inc | 40 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DEROYAL INDUSTRIES, INC.DeRoyal Industries · DEROYAL INDUSTRIES INC. · +1 | 34 | 2011–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | DeRoyal Industries Inc | 27 | 2012–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DeRoyal Industries, Inc.Deroyal Industries, Inc. · Deroyal Industries Inc. · +2 | 27 | 2001–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | DeRoyal Industries, Inc.DeRoyal Industries, Inc · DeRoyal industries | 14 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DEROYAL INDUSTRIES INC. | 4 | 2017–2023 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | DeRoyal Industries, Inc. | 3 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DEROYAL INDUSTRIES, INC. | 3 | 2016–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DEROYAL INDUSTRIES, INC | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 帝皇工业有限公司DeRoyal Industries, 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 DeRoyal Industries 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 |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | Cotton, Roll - DeRoyal | 2004 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Lister | Unit, Suction Operatory - DeRoyal | 2016 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Syringe, Periodontic, Endodontic, Irrigating - DeRoyal | 2017 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | Hemostat, Surgical - DeRoyal | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Absorber, Saliva, Paper - DeRoyal | 2023 |
| General Purpose Dental TrayOFX · Class 1 | — | Lister | General Purpose Dental Tray - DeRoyal | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Toothbrush, Manual - DeRoyal | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DeRoyal Industries, Inc.FDA reg. 1054241 | NEW TAZEWELL, TN, United States | Contract sterilizer |
| DeRoyal Industries, Inc.FDA reg. 1060680 | NEW TAZEWELL, TN, United States | Repacker / relabeler |
| DEROYAL INDUSTRIES, INC.FDA reg. 1043214 | POWELL, TN, United States | Complaint file establishment, Specification developer |
| DEROYAL INDUSTRIES, INC.FDA reg. 1055236 | NEW TAZEWELL, TN, United States | Contract sterilizer |
| DEROYAL INDUSTRIES, INC.FDA reg. 2320762 | NEW TAZEWELL, TN, United States | Contract manufacturer, Repacker / relabeler |
| DEROYAL INTERCONTINENTAL, S.R.L.FDA reg. 3004605321 | SANTIAGO, Dominican Republic | Contract manufacturer |
| Guatemala Medical ManufacturingFDA reg. 3045857302 | Villa Canales Guatemala, Guatemala | Contract manufacturer |
| Ortho and Surgical Products Enterprises S.A.FDA reg. 3010452421 | Villa Canales Guatemala, Guatemala | Contract manufacturer, Repacker / relabeler |
Other names on FDA records
Deroyal Intercontinental, S.A. · Ortho and Surgical Products Enterprises S.A. · Guatemala Medical Manufacturing
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1044833). 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.