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Rocky Mountain Orthodontics, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan — 4 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

14listed device types

Class I 14Class II 0Class III 0

plus 14 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

36registered devices

Class I 10Class II 26

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

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 States14 registration records, 21 510(k), 0 PMA

Brazil36 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: ROCKY MOUNTAIN REAGENTS, INC. · ROCKY MOUNTAIN ORTHODONTICS - RMO · ROCKY MONTAIN ORTHODONTICS INC. · ROCKY MOUNTAIN ORTHODONTICS INC · ROCKY MOUNTAIN ORTHODONTICS, INC - RMO · ROCKY MOUNTAIN ORTHODONTICS, INC.

Same-named companies — This database also contains companies with near-identical names: Rocky Mountain Biosystems, Inc., Rocky Mountain Medical Corp., ROCKY MOUNTAIN REAGENTS, INC., Rocky Mountain Research, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

41978

21983

21984

41985

11986

21989

11992

11994

21996

11999

12014

FDA listed device types

showing 8 of 14

Stains, Microbiologic 1Stain, Reticulocyte 1Toluidine Blue 1Carbol Fuchsin 1Safranin 1Methylene Blue, Tissue Stain 1Reagents, Specific, Analyte 1Iodine, Grams 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121123	BIOFUSIONARY BEBE	2014-03-10
US	K992857	LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070	1999-11-10
US	K961364	AUTOMATIC TUBING CLAMP SYSTEM (ATC)	1996-10-31
BR	80210490017	Resina Autopolimerizável TrulockTM	Class II
BR	80210490015	Trulock	Class II
BR	80210499007	Fio para ortodontia	Class II
SA	ME0000011793SFDAA00002	Orthodontic Plier	—
SA	ME0000011793SFDAA00005	Altitude SL	—

Rocky Mountain Orthodontics, 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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