Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009779268

FEI Number

3009779268

Entity Name

PANTHERA DENTAL INC

City/State/Country

Quebec City, CA

Establishment Address

9105 rue John-Simons, Quebec City G2B 0S6, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Panthera Dental Inc. (Owner Number: 10042081)

Owner / Operator Contact Address

9105 rue John-Simons, Quebec, CA-QC G2B 0S6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Panthera D-Guide Panthera Occlusal Appliance Panthera Dental Milled Bar Milled Bars Panthera Dental Panthera Anti-Snoring X3 Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2026-03-17
OCO	Mouthguard, Migraine/Tension Headache	Unknown	Class U	N/A	2021-11-09
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2021-11-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-02-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-12-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2018-02-28
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2012-10-17
EHO	Bar, Preformed	Dental	Class 1	872.3165	2012-10-17
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-02-09

Official Correspondent

Martine Fortin

US Agent Details

Meredith Jarigese Business: Panthera USA Email: mjarigese@pantheradental.com Phone: (714) 3120197

Related Public Records

Same Entity

Panthera Dental 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3013443455	VAMCO, LLC	Albuquerque, NM, US
3030268763	OWL DENTAL	San Leandro, CA, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009779268. Last updated year: 2026. Please use registration number 3009779268 when referencing this establishment in official correspondence.