Data / Medical devices / Canada / Dental Brands For Less

Dental Brands For Less: FDA-registered device maker in Markham Ontario, Canada, 6 510(k) clearances

Name: Dental Brands For Less FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dental Brands For Less is registered with the FDA (registration 3012312751) in Markham Ontario, Canada. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 23, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012312751
Address: 61 Amber Street, Markham Ontario, Canada, L3R3J7
Owner or operator: Dental Brands for Less (10052572)
Roles: Exporter to the US
First device listed: August 17, 2016
Registered through: 2026
Brand names listed: 3M ESPE, 3M-ESPE, Aquasil, Bausch, COLTENE, CROSSTEX, DENTSPLY, DIADENT and more

Devices it lists

Device	Product code	Class	Role	Source
Capsule, Dental, Amalgam	DZS	1	Exporter to the US	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US	accessdata.fda.gov
Dam, Rubber	EIE	1	Exporter to the US	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Exporter to the US	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Exporter to the US	accessdata.fda.gov
Material, Impression	ELW	2	Exporter to the US	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Exporter to the US	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Paper, Articulation	EFH	1	Exporter to the US	accessdata.fda.gov
Patient Examination Glove	FMC	1	Exporter to the US	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Exporter to the US	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 23, 2012	K121824	ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2	ELW	Substantially Equivalent	Lascod Spa	accessdata.fda.gov
April 9, 2003	K030414	GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL	ELW	Substantially Equivalent	Sultan Chemists, Inc.	accessdata.fda.gov
May 13, 2002	K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
August 17, 1999	K992337	BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA	FMC	Substantially Equivalent	Mexpo Intl., Inc.	accessdata.fda.gov
March 17, 1989	K883842	DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 7, 1986	K863174	CAULK'S POLISHING PASTE	EBF	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov

Compare with other makers

Updated August 23, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.