Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044167

FEI Number

3002772487

Entity Name

ROLENCE ENT. INC.

City/State/Country

CHUNGLI Taoyuan, TW

Establishment Address

18-3 LANE 231 PU CHUNG RD., CHUNGLI Taoyuan 32083, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ROLENCE ENT. INC. (Owner Number: 9005974)

Owner / Operator Contact Address

18-3 LANE 231 PU CHUNG RD., --, CHUNGLI, TW-TAO 32083, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202369

PMA Number

N/A

All Registered Proprietary Names

zoomcam elitedent crystal ; elitedent Extraoral X-Ray Unit PROPHY ANGLE Dental Burs ultra-lite q-lux elitedent 3-way syringes ROLENCE Dental High Speed Handpiece intelligence elitedent elegance Intraoral Digital X-Ray Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-02
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2008-11-04
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2018-06-09
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2018-06-09
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	1995-06-28
EJL	Bur, Dental	Dental	Class 1	872.3240	2005-04-13
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-11-02
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-03-15
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2009-12-21
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2007-11-02
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-10-29

Official Correspondent

STERLING CHENG

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

ROLENCE ENT. INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3011326671	STERI-SHIELD INCORPORATED	Fernandina Beach, FL, US
1824362	BIOTEC, INC.	ZEELAND, MI, US
3008344699	SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD.	Shang hai Shanghai, CN
3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044167. Last updated year: 2026. Please use registration number 8044167 when referencing this establishment in official correspondence.