FDA Product Code NUN: Bone Grafting Material, Human Source
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.
Leading manufacturers include Musculoskeletal Transplant Foundation, Osteotech, Inc. and Isotis NV.
15
Total
15
Cleared
169d
Avg days
2005
Since
FDA 510(k) Cleared Bone Grafting Material, Human Source Devices (Product Code NUN)
15 devices
Cleared
Jan 10, 2014
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
Hans Biomed Corp.
Dental
345d
Cleared
Jan 20, 2012
REGENEROSS ALLOGRAFT PLUS MINERLIZED
Biomet Interpore Cross
Dental
39d
Cleared
Aug 12, 2011
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
Exactech, Inc.
Dental
235d
Cleared
Oct 02, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
Musculoskeletal Transplant Foundation
Dental
158d
Cleared
Nov 10, 2008
PROGENIX
Medtronic Sofamor Danek
Dental
75d
Cleared
Jul 18, 2008
PROGENIX PLUS
Medtronic Sofamor Danek, Inc.
Dental
9d
Cleared
May 13, 2008
PROGENIX DBM PUTTY
Medtronic Sofamor Danek
Dental
83d
Cleared
May 14, 2007
INTERGRO ORAL
Biomet 3i
Dental
118d
Cleared
Mar 29, 2006
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
Isotis NV
Dental
48d
Cleared
Mar 27, 2006
ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
Isotis NV
Dental
48d
Cleared
Jan 03, 2006
GRAFTON DBM
Osteotech, Inc.
Dental
238d
Cleared
Nov 30, 2005
GRAFTON PLUS DBM PASTE
Osteotech, Inc.
Dental
426d
Cleared
Jul 29, 2005
DYNAGRAFT II DENTAL
Isotis Orthobiologics, Inc.
Dental
214d
Cleared
Apr 29, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
Musculoskeletal Transplant Foundation
Dental
428d