NUN

Bone Grafting Material, Human Source

Product code

NUN

Device name

Bone Grafting Material, Human Source

Device class

Class 2

21 CFR

21 CFR 872.3930

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

15 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).