Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006665149

FEI Number

3006665149

Entity Name

HENRY SCHEIN CANADA, INC.

City/State/Country

Niagara-on-the-Lake Ontario, CA

Establishment Address

345 Townline Road, Niagara-on-the-Lake Ontario L0S 1J0, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Henry Schein Canada, Inc. (Owner Number: 10055364)

Owner / Operator Contact Address

345 Townline Road, Niagara-on-the-Lake, CA-ON L0S 1J0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K924526

PMA Number

N/A

All Registered Proprietary Names

Solocem Henry Schein Earloop Procedure Masks DB+ 20 ANT FULL SET DB+ ANT EACH DB+ 20 POS FULL SET DB + POS EACH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-07-13
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-01-19
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2022-07-12

Official Correspondent

Naldo DeCicco

US Agent Details

Tracey Alexander Business: Henry Schein Inc. Email: Tracey.Alexander@HenrySchein.com Phone: (631) 4543003

Related Public Records

Same Entity

Henry Schein Canada, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

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3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006665149. Last updated year: 2026. Please use registration number 3006665149 when referencing this establishment in official correspondence.