Bone Graft Material for Dentistry
Notified Body #
- 0483
Internal CECP dossier #
Date of reception of the dossier
- 21.04.2021
Field of expert panel
- General and plastic surgery,
- Dentistry
Medical device type
[…] is an implantable device in contact with bone which is mainly resorbed.
[…] consists of porous granules of hydroxyapatite derived from porcine teeth.
Intended purpose
[…] is a medical device intended to be used as a bone graft material for the repair or augemntation of bone defects in dental procedures.
Risk class / type
- class III implantable
Screening step:
appropriate medical field
/ competence area
“Maxillofacial surgery & Dentistry (devices for dentistry/oral surgery, dental materials etc.) Maxillofacial surgery & Dentistry”
Novelty of device
and/or of related clinical procedure
- Novelty: Procedure is novel