NUN

Bone Grafting Material, Human Source

产品代码

NUN

器械名称

Bone Grafting Material, Human Source

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 872.3930

FDA 专业组

Dental

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

FDA 历史累计 510(k)

15 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。