Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807757

FEI Number

3002807757

Entity Name

NOVOCOL PHARMACEUTICAL OF CANADA, INC.

City/State/Country

Cambridge Ontario, CA

Establishment Address

25 Wolseley Court, Cambridge Ontario N1R 6X3, CA

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Novocol Pharmaceutical of Canada, Inc. (Owner Number: 10048017)

Owner / Operator Contact Address

25 Wolseley Court, Cambridge, CA-ON N1R 6X3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultra Safety Handle Biodentine Benco Henry Schein Safety Plus XL Patterson XL Septoject Darby Septoject Disposable Quala Safco Evolution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2014-11-25
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2015-04-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2015-04-29
DZM	Needle, Dental	Dental	Class 1	872.4730	2015-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

Jessenia Castillo Email: jcastillo@septodont.com Phone: (800) 8728305

Related Public Records

Same Entity

Novocol Pharmaceutical of 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807757. Last updated year: 2026. Please use registration number 3002807757 when referencing this establishment in official correspondence.