Manufacturer registered with FDA
Panthera Dental Inc.
Quebec, Canada. Lists 6 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 52014–2020
- Markets registered in
- 7107 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Panthera Dental Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Panthera Dental Inc. | 5 clearances | 2014–2020 | Below |
| Canada | Health Canada | Registration holder | PANTHERA DENTAL INC. | 93 | 2011–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Panthera Dental Inc. | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Panthera Dental Inc. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Panthera Dental Inc | 3 | 2022–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Panthera Dental Inc. | 2 | 2022–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | PANTHERA DENTAL INC. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Panthera Dental Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Dental Milled Bars PantheraMilled Bars Panthera DentalPanthera Dental Milled Bar | 2018 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Digital - Sleep Apnea DevicePanthera Anti-Snoring X3 DeviceThe Panthera Anti-Snoring Device | 2014 |
| All Precision AttachmentEGG · Class 1 | — | Maker | — | 2012 |
| Preformed BarEHO · Class 1 | — | Maker | — | 2012 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Panthera D-Guide | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Panthera Dental Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Apr 2020 | K192108 | Panthera Dental Milled Bars | NHA Endosseous Dental Implant Abutment |
| 20 Jun 2019 | K183580 | Panthera Dental Milled Bars | NHA Endosseous Dental Implant Abutment |
| 22 Feb 2018 | K171576 | The Panthera Anti-Snoring X3 Device | LRK Anti-Snoring Device |
| 26 Jan 2018 | K173466 | Panthera Dental Milled Bars | NHA Endosseous Dental Implant Abutment |
| 15 Dec 2014 | K143244 | The Panthera Anti-Snoring Device | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Apex Dental Sleep Lab (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PANTHERA DENTAL INCFDA reg. 3009779268 | Quebec City, Canada | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042081). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.