Registered with FDA
Riverside Medical Packaging Company Ltd
Derby, United Kingdom. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 4 markets
Where regulators' registries name Riverside Medical Packaging Company Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Riverside Medical Packaging Company Ltd | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | RIVERSIDE MEDICAL PACKAGING COMPANY LTD. | 3 | 2005–2006 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Riverside Medical Packaging Company Ltd | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Riverside Medical Packaging Co. Ltd. | 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 Riverside Medical Packaging Company Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | — | 2013 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2020 |
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
Riverside Medical Packaging Company Ltd 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: DB Orthodontics Limited (2), Osstell AB (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Apr 2014 | K132401 | MEGA ISQ | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 1 Apr 2010 | K100633 | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 | DB Orthodontics Limited | OAT Orthodontic Endosseous Implant |
| 26 Oct 2007 | K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | DB Orthodontics Limited | OAT Orthodontic Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RIVERSIDE MEDICAL PACKAGING COMPANY LTDFDA reg. 3008559295 | Derby Derbyshire, United Kingdom | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033563). 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.