Registered with FDA
Dentamerica
City of Industry, CA, United States. Lists 20 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 16
- 510(k) clearances
- 41996–2010
- Markets registered in
- 826 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 8 markets
Where regulators' registries name Dentamerica as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Dentamerica | 4 clearances | 1996–2010 | Below |
| Taiwan | TFDA | Manufacturer | DENTAMERICA INC. | 10 | 2011–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DENTAMERICADentamerica | 5 | 2001–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DENTAMERICA | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTAMERICA | 4 | 2018–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Dentamerica | 1 | 2005–2005 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DENTAMERICA | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DENTAMERICA | 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 Dentamerica currently lists, by FDA device type, with the brand and model names on the listing.
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 Dentamerica as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Jan 2010 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | EKX Ac-Powered Direct Drive Handpiece |
| 24 Apr 2006 | K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 18 Jan 1996 | K954820 | SCALEX 800 | ELC Ultrasonic Scaler |
| 2 Jan 1996 | K955759 | LITEX 680 | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: Dhef Inc. (4), Essential Dental Systems, Inc. (1).
Also lists devices cleared under other names
Dentamerica 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: Apixia, Inc. (1), Dentsply Sirona, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 May 2012 | K120106 | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM | Apixia, Inc. | MUH Digital Extraoral Source X-Ray System |
| 29 Jan 1998 | K974704 | HYDROGUM | Dentsply Sirona, Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTAMERICAFDA reg. 2024949 | City of Industry, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2024949). 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.