Registered with FDA
Pharmco Medical B.V.
ROTTERDAM, Netherlands. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Netherlands
Devices listed with FDA
What Pharmco Medical B.V. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2025 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2024 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | — | 2024 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | — | 2024 |
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
Pharmco Medical B.V. 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: Shofu Inc (4), Zimmer Dental, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Jul 2016 | K160596 | BEAUTIFIL II LS | Shofu Inc | EBF Resin Tooth Shade Material |
| 1 Oct 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | Zimmer Dental, Inc. | DZE Root-Form Endosseous Implant |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 24 Aug 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | Shofu Inc | EMA Dental Cement |
| 25 Apr 1986 | K861005 | GLASIONOMER BASE CEMENT | Shofu Inc | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PHARMCO MEDICAL BVFDA reg. 3030447506 | ROTTERDAM Zuid-Holland, Netherlands | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089125). 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.