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Henry Schein, Inc.

USA · Melville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 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

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

66active ARTG entries

Class I 37IIa 25Class Is (sterile) 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 CANADA, INC., Henry Schein One, LLC, HENRY SCHEIN SERVICES GMBH. Company name alone cannot separate their registrations, so the figures below may include either.

Business registration

Legal name: HENRY SCHEIN INC
CIK: 0001000228
Registration status: Active
Listing status: Listed (HSIC)

Business registration data from SEC EDGAR, 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)

Market	Identifier	Name	Class / date
US	K041580	IMAGERAYI	2004-06-29
US	K862384	SCHEIN AP-1 AIR POLISHING UNIT	1986-11-07
US	K862385	SCHEIN BLEACHING UNIT	1986-10-30
CA	61460	ARCONA SELECT CARBIDE BURS	Class II
CA	76299	HENRY SCHEIN QUICK SEPARATING RINGS-BLUE	Class II
CA	76300	HENRY SCHEIN LINGUAL RETAINER	Class II

Henry Schein, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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