Manufacturer registered with FDA
Reco-Dent International Co., Ltd.
New Taipei City, Taiwan. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 217 registrations outside the US
- Establishments
- 1Taiwan
Registered in 2 markets
Where regulators' registries name Reco-Dent International Co., Ltd. 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 | Reco-Dent International Co., Ltd. | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | RECO-DENT INTERNATIONAL CO., LTDRECO-DENT INTERNATIONAL CO.,LTD · Reco-Dent International Co., Ltd. · +2 | 17 | 1999–2025 | 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 Reco-Dent International Co., Ltd. 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 | Dental Diamond Instrument | 1998 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Abrasive Disk | 2000 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Cup | 2000 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Bur | 2000 |
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 |
|---|---|---|
| RECO-DENT INTL. CO., LTD.FDA reg. 9615845 | NEW TAIPEI CITY, Taiwan | Foreign exporter, Manufacturer |
Other names on FDA records
Reco-Dent Intl. Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9035291). 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.