NUN

15 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bone Grafting Material, Human Source

Device class

Class II (moderate risk)

Regulation

21 CFR 872.3930

Medical specialty

Dental

Flags

Implant

FDA definition

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.

Adverse events (MAUDE)

2010: 6 · 2011: 13 · 2012: 15 · 2013: 25 · 2017: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free