Data / Medical devices / France / Bio Composants Medicaux (BCM)
Bio Composants Medicaux (BCM): FDA-registered device maker in SAINT BLAISE DU BUIS Isere, France, 1 510(k) clearance
Bio Composants Medicaux (BCM) is registered with the FDA (registration 3008757014) in SAINT BLAISE DU BUIS Isere, France. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 23, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008757014
- Address
- 215 Route de Bavonne ZA Le Talamud, SAINT BLAISE DU BUIS Isere, France, 38140
- Owner or operator
- BIO COMPOSANTS MEDICAUX (BCM) (10035008)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 25, 2011
- Registered through
- 2026
- Brand names listed
- Fiber Force products (repackaged product of Fast Splint)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2010 | K102207 | FIBER FORCE | EBI | Substantially Equivalent | Synca Marketing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Post, Root Canal
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Drill, Dental, Intraoral
Updated November 23, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.