Data / Medical devices / Canada / Proto3000 Inc.

Proto3000 Inc.: FDA-registered device maker in Vaughan Ontario, Canada, 9 510(k) clearances

Name: Proto3000 Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Proto3000 Inc. is registered with the FDA (registration 3013343038) in Vaughan Ontario, Canada. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 11, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013343038
Address: 6260 Highway 7 Unit 8, Vaughan Ontario, Canada, L4H4G3
Owner or operator: Proto3000 Inc. (10086557)
Roles: Manufacturer
First device listed: August 16, 2023
Registered through: 2026
Brand names listed: Dental Direkt GmbH, Exocad Exoplan, Medit Scanner, Upcera, Vertex-Dental B.V.

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	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
January 11, 2023	K191111	DD Solid Connect® CAD/CAM Abutments	NHA	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
October 21, 2022	K221022	NextDent Ortho Flex	MQC	Substantially Equivalent	Vertex-Dental B.V.	accessdata.fda.gov
July 21, 2021	K193352	AbutmentCAD	PNP	Substantially Equivalent	Exocad GmbH	accessdata.fda.gov
April 16, 2020	K193588	DD Contrast	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
November 1, 2019	K191497	NextDent Denture 3D+	EBI	Substantially Equivalent	Vertex-Dental B.V.	accessdata.fda.gov
February 14, 2019	K183569	DD cube ONE ML	EIH	Substantially Equivalent	Dental Direkt GmbH	accessdata.fda.gov
June 30, 2017	K162572	NextDent Denture, E-Denture	EBI	Substantially Equivalent	Vertex-Dental B.V.	accessdata.fda.gov
March 1, 2013	K123220	VERTEX THERMOSENS RIGID	EBI	Substantially Equivalent	Vertex-Dental B.V.	accessdata.fda.gov
January 28, 2010	K093560	UPCERA ZIRCONIA BLANKS	EIH	Substantially Equivalent	Shenyang Upcera Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 11, 2023. 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.