Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009655316

FEI Number

3009655316

Entity Name

Smarter Alloys

City/State/Country

Cambridge Ontario, CA

Establishment Address

221 Shearson Cres, Cambridge Ontario N1T1J5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smarter Alloys Inc (Owner Number: 10048942)

Owner / Operator Contact Address

221 Shearson Cres, Cambridge, CA-ON N1T1J5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Paradigm SmartArch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2019-02-10
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2015-03-23

Official Correspondent

Mohammed Khan

US Agent Details

Ayesha Sultan Email: us_agent@smarteralloys.com Phone: (832) 7942499

Related Public Records

Same Entity

Smarter Alloys 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3042158426	INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI	Istanbul, TR
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009655316. Last updated year: 2026. Please use registration number 3009655316 when referencing this establishment in official correspondence.