Not currently registered with FDA under this name
Rolence Enterprise, Inc.
Taoyuan, Taiwan. Named as applicant on 14 dental 510(k) clearances between 1993 and 2021. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 141993–2021
- Markets registered in
- 767 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Rolence Enterprise, 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 | Applicant | Rolence Enterprise, Inc. | 14 clearances | 1993–2021 | Below |
| South Korea | MFDS | Manufacturer | Rolence Enterprise Inc.ROLENCE ENTERPRISE INC · Rolence Enterprise INC. · +2 | 39 | 1999–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Rolence Enterprise Inc. | 14 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ROLENCE ENTERPRISE INC. | 10 | 2010–2017 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Rolence Enterprise Inc. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Rolence Enterprise Co Ltd | 1 | 2008–2008 | Pure Global AI |
| Israel | AMAR | Manufacturer | Rolence Enterprise 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
510(k) clearances
Clearances on which FDA names Rolence Enterprise, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Sep 2021 | K202369 | RXS 1000 | MUH Digital Extraoral Source X-Ray System |
| 16 Mar 2018 | K172928 | Portable X-ray System | EHD Extraoral with Timer X-Ray Unit |
| 10 Oct 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 20 Jul 1999 | K991865 | Q-LITE 75 LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 19 Jul 1999 | K991863 | CUTE-LITE I LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 15 May 1998 | K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | EBF Resin Tooth Shade Material |
| 15 May 1998 | K980792 | CU-100A LIGHT CURE UNIT | EBF Resin Tooth Shade Material |
| 15 Apr 1996 | K960364 | CU-200 LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 15 Apr 1996 | K960351 | Q-LUX LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 29 Sep 1995 | K953628 | PROPHY ANGLE | EHK Prophylaxis Cup |
| 22 Jun 1995 | K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | EBZ Ultraviolet Activator for Polymerization |
| 2 Jun 1994 | K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | EBZ Ultraviolet Activator for Polymerization |
| 27 May 1994 | K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | EBZ Ultraviolet Activator for Polymerization |
| 17 Jun 1993 | K924727 | 100 LIGHT CURE UNIT | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Rolence Ent., Inc. (3).
Sources
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 of the most recent filing, which can be a US agent.