Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013343038

FEI Number

3013343038

Entity Name

PROTO3000 INC.

City/State/Country

Vaughan Ontario, CA

Establishment Address

6260 Highway 7, Unit 8, Vaughan Ontario L4H4G3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Proto3000 Inc. (Owner Number: 10086557)

Owner / Operator Contact Address

6260 Highway 7, Unit 8, Vaughan, CA-ON L4H4G3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162572

PMA Number

N/A

All Registered Proprietary Names

Vertex-Dental B.V. Medit Scanner Dental Direkt GmbH Upcera Exocad Exoplan Vertex-Dental B.V.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-08-16
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2023-08-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-08-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-08-16
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2023-08-16
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2023-08-16

Official Correspondent

Louie Canitano

US Agent Details

Lawerence Petersen Business: Medical Devices International Email: larrypetersen7@gmail.com Phone: (303) 4892500

Related Public Records

Same Entity

Proto3000 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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013343038. Last updated year: 2026. Please use registration number 3013343038 when referencing this establishment in official correspondence.