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Product Classification / EMDN Category

FDA Product Code: Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1

Directory of devices assigned to product classification code Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1.

enforcement NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -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 intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration Manufacturer: Collagen Matrix Inc

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