HomeCanadaHENRY SCHEIN CANADA, INC.

HENRY SCHEIN CANADA, INC.

Canada · Niagara-On-The-Lake
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
15listed device types
Class I 7Class II 8Class III 0
plus 25 registration records and 8 510(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
4active device licences
Class II 4
187 including historic records
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 States25 registration records, 8 510(k), 0 PMA
Saudi Arabia0 confirmed, 1 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: HENRY SCHEIN MSO, LLC · Henry Schein One, LLC · HENRY SCHEIN CANADA, INC. · HENRY SCHEIN SERVICES GMBH · HENRY SCHEIN CANADA INC. · HENRY SCHEIN INC.
Same-named companies — This database also contains companies with near-identical names: Henry Schein, Inc., Henry Schein One, LLC, HENRY SCHEIN SERVICES GMBH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Niagara-On-The-Lake

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
HENRY SCHEIN ARCONA INC.
Corporation number
3114091
Registration status
Inactive
Legal form
Canada Business Corporations Act
Incorporated
1995-01-31
Registered address
17 KEEFER ROAD, ST CATHARINES, ON, L2M6K4

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11978 · K781592
11980 · K801079
31984 · K841199
21986 · K862384
12004 · K041580

FDA listed device types

showing 8 of 15
Absorber, Saliva, Paper 1Handpiece, Air-Powered, Dental 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Mirror, Mouth 1Scissors, Orthopedic, Surgical 1Medical Device Data System 1Articulators 1Handpiece, Rotary Bone Cutting 1

Registration details (sample)

MarketIdentifierNameClass / date
USK041580IMAGERAYI2004-06-29
USK862384SCHEIN AP-1 AIR POLISHING UNIT1986-11-07
USK862385SCHEIN BLEACHING UNIT1986-10-30
CA61460ARCONA SELECT CARBIDE BURSClass II
CA76299HENRY SCHEIN QUICK SEPARATING RINGS-BLUEClass II
CA76300HENRY SCHEIN LINGUAL RETAINERClass II

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