3 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
FDA Enforcement
Class III
·Terminated·Collagen Matrix, Inc.·November 21, 2018
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
FDA Enforcement
Class III
·Terminated·Collagen Matrix Inc·March 23, 2016
Porcine Anorganic Bone Mineral 4.0cc
FDA Enforcement
Class III
·Terminated·Collagen Matrix Inc·January 23, 2019