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Rolence Ent., Inc.

Taiwan · Chungli Taoyuan

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 8Class II 4Class III 0

plus 12 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 5 510(k), 0 PMA, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ROLENCE ENT. INC.

FDA 510(k) clearances by year

42002 · K023545

12009 · K093084

FDA listed device types

showing 8 of 12

Unit, Syringe, Air And/Or Water 1Bur, Dental 1Handpiece, Air-Powered, Dental 1Warmer, Anesthetic Tube 1Unit, Operative Dental 1Cup, Prophylaxis 1Heat Source For Bleaching Teeth 1Mouthpiece, Saliva Ejector 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093084	ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP	2009-12-16
US	K023545	ULTRA-LITE 200E LIGHT CURE UNIT	2002-12-30
US	K020877	EXCELLITE TURBO LIGHT CURE UNIT	2002-06-12

Rolence Ent., Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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