Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008757014

FEI Number

3008757014

Entity Name

BIO COMPOSANTS MEDICAUX (BCM)

City/State/Country

SAINT BLAISE DU BUIS Isere, FR

Establishment Address

215 Route de Bavonne, ZA Le Talamud, SAINT BLAISE DU BUIS Isere 38140, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

BIO COMPOSANTS MEDICAUX (BCM) (Owner Number: 10035008)

Owner / Operator Contact Address

215 route de Bavonne, Saint Blaise Du Buis, FR-38 38140, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fiber Force products (repackaged product of Fast Splint)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-01-25
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2022-10-24

Official Correspondent

Leonie Biserta

US Agent Details

Patrizia Manna Business: Synca Direct Email: patrizia.m@synca.com Phone: (888) 5828115

Related Public Records

Same Entity

BIO COMPOSANTS MEDICAUX (BCM)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008757014. Last updated year: 2026. Please use registration number 3008757014 when referencing this establishment in official correspondence.