EthOss TCP - Dental bone matrix implant, synthetic
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
28-05-2019
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Tilgængelig fra:
W9 Pty Ltd
Klasse:
Class III
Fremstillet af:
Medbone-Medical Devices Lda Centro Empresarial Lusoworld II R Pe de Mouro 26 , Sintra, 2710-335 Portugal
Terapeutisk område:
47971 - Dental bone matrix implant, synthetic
Terapeutiske indikationer:
EthOss TCP is a synthetic, resorbable, osteoconductive bone graft material composed of 65% beta tricalcium phosphate (?-TCP) and 35% medical grade calcium sulfate (CaSO4). It is provided as a dry powder packaged within a syringe to be mixed with sterile saline to form a paste and applied through the syringe. EthOss TCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Autorisation status:
A
Autorisation dato:
2018-02-22
