Manufacturer registered with FDA
Rolence Ent., Inc.
CHUNGLI, Taiwan. Lists 12 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 19
- 510(k) clearances
- 52002–2009
- Markets registered in
- 1United States
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Rolence Ent., 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Extraoral X-Ray UnitIntraoral Digital X-Ray Sensor | 2018 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | SALIVA EJECTOR | 1995 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | elitedentq-luxultra-lite | 2007 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | 3-way syringes | 2011 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | crystal ; elitedent | 2008 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dental High Speed HandpieceROLENCE | 2009 |
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | Composite / Resin Heater | 2015 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Extraoral X-Ray Unit | 2018 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | PROPHY ANGLE | 1995 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | elitedentzoomcam | 2007 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs | 2005 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | eleganceelitedentintelligence | 2007 |
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 Rolence Ent., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Dec 2009 | K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | EFB Dental Air-Powered Handpiece |
| 30 Dec 2002 | K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 12 Jun 2002 | K020884 | EXCELLITE LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 12 Jun 2002 | K020877 | EXCELLITE TURBO LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
| 12 Jun 2002 | K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: 3D Dental Designs and Development LLC (1).
Also lists devices cleared under other names
Rolence Ent., Inc. 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: Rolence Enterprise, Inc. (3), Rolence Enteprise, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Sep 2021 | K202369 | RXS 1000 | Rolence Enterprise, Inc. | MUH Digital Extraoral Source X-Ray System |
| 16 Mar 2018 | K172928 | Portable X-ray System | Rolence Enterprise, Inc. | EHD Extraoral with Timer X-Ray Unit |
| 11 Feb 2005 | K043325 | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES | Rolence Enteprise, Inc. | EIA Operative Dental Unit |
| 22 Apr 2004 | K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Rolence Enteprise, Inc. | ELC Ultrasonic Scaler |
| 10 Oct 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | Rolence Enterprise, Inc. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ROLENCE ENT. INC.FDA reg. 8044167 | CHUNGLI Taoyuan, Taiwan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005974). 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.