Manufacturer registered with FDA
Dedeco International, Inc.
Long Eddy, NY, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 426 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Dedeco International, 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 | Dedeco International, Inc. | 7 device types | — | Below |
| South Korea | MFDS | Manufacturer | Dedeco International Inc.Dedeco International, Inc. · DEDECO INTERNATIONAL INC. · +1 | 16 | 1999–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DEDECO INTERNATIONAL,INCDEDECO INTERNATIONAL, INC | 5 | 2009–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DEDECO INTERNATIONAL INC. | 5 | 2006–2021 | 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 Dedeco 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 |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Instrument Diamond DentalPoint Abrasive | 2001 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2020 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Disk Abrasive | 2001 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Point Abrasive | 2001 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bur, Dental | 2001 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Agent, Polishing, Abrasive, Oral Cavity | 2001 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss Dental | 2020 |
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 |
|---|---|---|
| Dedeco International, Inc.FDA reg. 1316367 | LONG EDDY, NY, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1316367). 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.