MORE THAN 1000 SCIENTIFIC PUBLICATIONS ON NACRE AVAILABLE.
FOR ANY QUESTION CONTACT US.

ARTIFICIAL DENTAL ROOT
Article Drs Camprasse 1991
Substitution De La Racine Dentaire Sur L'homme 1988 Academie Des Sciences
In Vivo Erosion Of Orthopedic Screws
Scientific Publication Pr Chapprd 2014
Capture d’écran 2017-11-23 à 12.12.42
Osteointegration-et-erosion

SOME SCIENTIFIC INFORMATION ABOUT NACRE :

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Scientific Data – 25 years clinical experience and evaluation

 

• In vitro data, in particular in contact with human osteoblast cells, showing the full biocompatibility as well as the osteogenic properties

• In vivo preclinical data (sheep, rabbits), about the use of plates and screws for orthopedics, which have demonstrated the osseointegration and were subject of publications

• Data collected on human clinical cases (dental, orthopedics), in particular through the use of the powdered form of the biomaterial (bone substitute, for reconstruction of alveolar ridge or loss of substance for example).

• Complete Clinical Evaluation in accordance with the regulatory requirements (MEDDEV 2.7/1 rev.4)

 

 

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Safety of the manufacturing process

 

In a regulatory strictly controlled environment.

 

• ISO 13485:2012 company certification.

• By product, conception, development, production and post-market conditions in accordance with the requirements for Medical Device regulatory compliance.

• For each form of the biomaterial (powdered or solid), different controls in each key process step for a full safety and traceability evidence.

• Since the preparation and the receival of the raw material, several steps of pre-process decontamination and cleaning steps.

• During the manufacturing process, several physico-chemical treatments and externally completed biological tests in order to prevent from any production out-of-specifications.

• At the end of the process, sterilization through Gamma irradiation method.

• Post-market surveillance, in collaboration with professional leaders of distribution.

 

Mega Bio Pharma®