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RELIANCE ORTHODONTIC PRODUCTS, INC.

USA · Itasca

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

26listed device types

Class I 16Class II 10Class III 0

plus 58 registration records and 33 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

35 including historic records

TWTaiwanTFDA

8valid device licences

Class I 2Class II 6

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

Class I 4IIa 8

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States58 registration records, 33 510(k), 0 PMA, 10 excluded

Brazil13 confirmed, 1 excluded

Saudi Arabia3 confirmed, 2 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: RELIANCE ORTHODONTIC PRODUCTS, INC. · RELIANCE ORTHODONTIC PRODUCTS INC. · Reliance Orthodontic Products, Inc. · Reliance Orthodontic Products Inc.

FDA 510(k) clearances by year

11983

101988

61989

11993

11994

12000

12003

22007

12008

12009

12010

12011

22013

12016

12020

22021

FDA listed device types

showing 8 of 26

Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Powder, Porcelain 1Material, Tooth Shade, Resin 1Airbrush 1Aligner, Sequential 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210349	TKO Composite Bite Turbo Gel	2021-07-20
US	K210945	Ultra SEP	2021-07-08
US	K193388	GlassLok Kits, GlassLok Powder, GlassLok Liquid	2020-04-27
BR	80743689002	ASSURE PLUS	Class II
BR	80743689003	Renew Finishing System Burs	Class II
BR	80743689004	Bond Aligner 1.4g Clear Aligner Adhesive	Class II
SA	ME0000011816SFDAA00015	Ortho Flex Tech®	—
SA	ME0000011816SFDAA00016	Bond A braid	—
CA	72322	ENHANCE - ORTHODONTIC CONDITIONER	Class II
CA	83496	QUICK CURE	Class II
CA	83500	CUSTOM IQ	Class II