Manufacturer registered with FDA
AMD Medicom Inc
Pointe Claire, Canada. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 32
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6146 registrations outside the US
- Establishments
- 1Canada
Registered in 6 markets
Where regulators' registries name AMD Medicom 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 | AMD Medicom Inc | 12 device types | — | Below |
| Canada | Health Canada | Registration holder | AMD MEDICOM INC. | 121 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | AMD MEDICOM INC. | 22 | — | Pure Global AI |
| Australia | TGA | Manufacturer | AMD Medicom Inc | 1 | 2024–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AMD Medicom Inc | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | AMD Medicom 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 AMD Medicom 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 |
|---|---|---|---|---|
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | Medicom Duraflor Halo VarnishMedicom Duraflor Varnish | 2016 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Medicom Prophy AngleProphy Angle | 2024 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Hedy Saliva EjectorsMedicom High Suction TipsMedicom Saliva Ejectors | 2008 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Medicom Pro-Matrix Band | 2016 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Hedy Air/Water Syringe TipHedy Intra Oral TipsPro-SyringePro-Tip Turbo Converter AdecPro-Tip Turbo Converter DCIPro-Tip Turbo Converter DentalEZPro-Tip Turbo Converter EnglePro-Tip Turbo Syringe Tip | 2016 |
| Roll CottonEFN · Class 1 | — | Maker | Hedy Cotton Dental RollsMedicom Cotton Roll | 2007 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Hedy Dental DamMedicom Dental Dam | 2016 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Medicom Denticare Pro-Polish | 2014 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Medicom SafeMatrix Band | 2020 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Hedy Patient BibsMedicom Dental Bib | 2011 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Medicom Disposable Gel Tray | 2016 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Hedy Air/Water SleeveHedy Chair SleeveHedy Headrest coverHedy Tray SleeveHedy X-Ray Sensor SleeveMedicom Dental Tray CoverMedicom Headrest Cover | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
AMD Medicom Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Pacific Care Limited (1), Young Innovations Inc (1), Nanova Biomaterials Inc (1), Medical Products Laboratories, Inc. (1), Pac-Dent International (Suzhou), Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 May 2025 | K240950 | Disposable Prophy Angle | Pacific Care Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 20 May 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Innovations Inc | LBH Cavity Varnish |
| 22 Sep 2014 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Nanova Biomaterials Inc | LBH Cavity Varnish |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMD Medicom Inc.FDA reg. 9611959 | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Foreign exporter, Private-label distributor, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8020405). 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.