Data / Medical devices / Canada / Panthera Dental Inc

Panthera Dental Inc: FDA-registered device maker in Quebec City, Canada, 6 510(k) clearances

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

Panthera Dental Inc is registered with the FDA (registration 3009779268) in Quebec City, Canada. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 20, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009779268
Address: 9105 rue John-Simons, Quebec City, Canada, G2B 0S6
Owner or operator: Panthera Dental Inc. (10042081)
Roles: Complaint file establishment, Manufacturer
First device listed: October 17, 2012
Registered through: 2026
Brand names listed: Dental Milled Bars Panthera, Digital - Sleep Apnea Device, Milled Bars Panthera Dental, Panthera Anti-Snoring X3 Device, Panthera D-Guide, Panthera Dental Milled Bar, Panthera Occlusal Appliance, The Panthera Anti-Snoring Device

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bar, Preformed	EHO	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mouthguard, Migraine/Tension Headache	OCO	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Complaint file establishment, 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
April 20, 2021	K203596	Panthera Occlusal Appliance	MQC	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov
April 8, 2020	K192108	Panthera Dental Milled Bars	NHA	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov
June 20, 2019	K183580	Panthera Dental Milled Bars	NHA	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov
February 22, 2018	K171576	The Panthera Anti-Snoring X3 Device	LRK	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov
January 26, 2018	K173466	Panthera Dental Milled Bars	NHA	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov
December 15, 2014	K143244	The Panthera Anti-Snoring Device	LRK	Substantially Equivalent	Panthera Dental, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 20, 2021. 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.