Registered with FDA
Biocells Discoveries Internacional (Biocells)
Quito, Ecuador. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Ecuador
Devices listed with FDA
What Biocells Discoveries Internacional (Biocells) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | 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
Biocells Discoveries Internacional (Biocells) 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: W&H Dentalwerk Buermoos GmbH (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 3 May 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS)FDA reg. 3021336182 | Quito Pichincha, Ecuador | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083835). 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.