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Panthera Dental, Inc.

Canada · Quebec

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 2Class III 0unclassified 2

plus 10 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 2Class III 1

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 6 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: PANTHERA DENTAL INC · PANTHERA DENTAL INC.

FDA 510(k) clearances by year

12014 · K143244

22018 · K171576

12019 · K183580

12020 · K192108

12021 · K203596

FDA listed device types

Device, Anti-Snoring 1Abutment, Implant, Dental, Endosseous 1Attachment, Precision, All 1Accessories, Implant, Dental, Endosseous 1Tray, Impression, Preformed 1Bar, Preformed 1Mouthguard, Prescription 1Mouthguard, Migraine/Tension Headache 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203596	Panthera Occlusal Appliance	2021-04-20
US	K192108	Panthera Dental Milled Bars	2020-04-08
US	K183580	Panthera Dental Milled Bars	2019-06-20
CA	85654	FORET - ACIER INOXYDABLE	Class II
CA	100001	SYSTEME ORTRAUTEK D'OSTEOSYNTHESE CRANIO-MAXILLO-FACIALE	Class III
CA	103824	ANGULATED SCREWDRIVER BITS	Class II

Panthera Dental, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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