Registered with FDA
Innopex Limited
Concord, Canada. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What Innopex 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 |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | — | 2020 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | — | 2023 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | — | 2022 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | 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
Innopex Limited 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: Procter & Gamble (3), Shofu Inc (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 24 Sep 2009 | K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble | JES Dental Floss |
| 5 Jun 2006 | K061351 | ORAL-B SONIC COMPLETE | Procter & Gamble | JEQ Powered Toothbrush |
| 26 Aug 1988 | K883024 | ORAL-B FLOSSERS | Procter & Gamble | JES Dental Floss |
| 29 Sep 1983 | K832855 | TPE DIAMOND POINTS | Shofu Inc | DZP Dental Diamond Instrument |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INNOPEX LIMITEDFDA reg. 3001124136 | Toronto Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047406). 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.