DeviceClearance

Product code NUN— Dental

ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY

Classification name
Bone Grafting Material, Human Source
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Total cleared
15
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NUN under 21 CFR 872.3930, via openFDA

Market context for product code NUN

FDA has cleared 15 devices under product code NUN between 2005 and 2014, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NUN

Recent clearances under product code NUN

Data sourced from openFDA. This site is unofficial and independent of the FDA.