Manufacturer registered with FDA
Bio Composants Medicaux (BCM)
Saint Blaise Du Buis, France. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 236 registrations outside the US
- Establishments
- 1France
Registered in 2 markets
Where regulators' registries name Bio Composants Medicaux (BCM) 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 | Bio Composants Medicaux (BCM) | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | BIO COMPOSANTS MEDICAUX (BCM) | 36 | 2007–2014 | 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 Bio Composants Medicaux (BCM) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2022 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Fiber Force products (repackaged product of Fast Splint) | 2011 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | — | 2017 |
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
Bio Composants Medicaux (BCM) 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: Synca Marketing (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 2010 | K102207 | FIBER FORCE | Synca Marketing | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIO COMPOSANTS MEDICAUX (BCM)FDA reg. 3008757014 | SAINT BLAISE DU BUIS Isere, France | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035008). 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.