Data / Medical devices / Taiwan / Rolence Ent. Inc.

Rolence Ent. Inc.: FDA-registered device maker in CHUNGLI Taoyuan, Taiwan, 6 510(k) clearances

Name: Rolence Ent. Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Rolence Ent. Inc. is registered with the FDA (registration 8044167) in CHUNGLI Taoyuan, Taiwan. It lists 12 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 15, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8044167
FEI number: 3002772487
Address: 18-3 Lane 231 Pu Chung RD., CHUNGLI Taoyuan, Taiwan, 32083
Owner or operator: ROLENCE ENT. INC. (9005974)
Roles: Exporter to the US, Manufacturer
First device listed: June 28, 1995
Registered through: 2026
Brand names listed: 3-way syringes, Composite / Resin Heater, Dental Burs, Dental High Speed Handpiece, Extraoral X-Ray Unit, Intraoral Digital X-Ray Sensor, PROPHY ANGLE, ROLENCE and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Warmer, Anesthetic Tube	EFC	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2021	K202369	RXS 1000	MUH	Substantially Equivalent	Rolence Enterprise, Inc.	accessdata.fda.gov
March 16, 2018	K172928	Portable X-ray System	EHD	Substantially Equivalent	Rolence Enterprise, Inc.	accessdata.fda.gov
December 16, 2009	K093084	ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP	EFB	Substantially Equivalent	Rolence Ent., Inc.	accessdata.fda.gov
February 11, 2005	K043325	ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES	EIA	Substantially Equivalent	Rolence Enteprise, Inc.	accessdata.fda.gov
April 22, 2004	K040396	ULTRASONIC SCALER ELEGANCE MS-10 (25K)	ELC	Substantially Equivalent	Rolence Enteprise, Inc.	accessdata.fda.gov
October 10, 2000	K001719	Q-LUX PLASMA 100 LIGHT CURE UNIT	EBZ	Substantially Equivalent	Rolence Enterprise Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 15, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.