Manufacturer registered with FDA
Medivance Instruments Limited
HARLESDEN, LONDON, United Kingdom. Lists 2 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12003–2003
- Markets registered in
- 940 registrations outside the US
- Establishments
- 2United Kingdom, United States
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Medivance Instruments Limited 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 | Medivance Instruments Limited | 1 clearances | 2003–2003 | Below |
| Canada | Health Canada | Registration holder | MEDIVANCE INSTRUMENTS LTD. | 10 | 2011–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Medivance Instruments Limited | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Medivance Instruments Limited | 7 | 2003–2016 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medivance Instruments Ltd.Medivance Instruments | 5 | 1999–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDIVANCE INSTRUMENTS LTD | 4 | 2016–2021 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medivance Instruments Limited | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Medivance Instruments Ltd. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDIVANCE INSTRUMENTS LTD | 1 | 2025–2025 | 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 Medivance Instruments Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | BAG 45S5 | 2023 |
| AirbrushKOJ · Class 2 | — | Maker | Aquacut Quattro AquaCare Twin, AquaCare Single | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDIVANCE INSTRUMENTS LTD.FDA reg. 3003982003 | HARLESDEN, LONDON London, City of, United Kingdom | Manufacturer |
| VELOPEX INTERNATIONAL, INC.FDA reg. 3003697084 | Saint Cloud, FL, United States | Complaint file establishment |
Other names on FDA records
Velopex International, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9051184). 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.