NUN · Class II · 21 CFR 872.3930

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
1–15 of 15
Cleared Jan 10, 2014
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
K130235
Hans Biomed Corp.
Dental · 345d
Cleared Jan 20, 2012
REGENEROSS ALLOGRAFT PLUS MINERLIZED
K113645
Biomet Interpore Cross
Dental · 39d
Cleared Aug 12, 2011
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
K103699
Exactech, Inc.
Dental · 235d
Cleared Oct 02, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091217
Musculoskeletal Transplant Foundation
Dental · 158d
Cleared Nov 10, 2008
PROGENIX
K082463
Medtronic Sofamor Danek
Dental · 75d
Cleared Jul 18, 2008
PROGENIX PLUS
K081950
Medtronic Sofamor Danek, Inc.
Dental · 9d
Cleared May 13, 2008
PROGENIX DBM PUTTY
K080462
Medtronic Sofamor Danek
Dental · 83d
Cleared Apr 30, 2008
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
K080418
Regeneration Technologies, Inc.
Dental · 75d
Cleared May 14, 2007
INTERGRO ORAL
K070147
Biomet 3i
Dental · 118d
Cleared Mar 29, 2006
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K060332
Isotis NV
Dental · 48d
Cleared Mar 27, 2006
ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
K060306
Isotis NV
Dental · 48d
Cleared Jan 03, 2006
GRAFTON DBM
K051188
Osteotech, Inc.
Dental · 238d
Cleared Nov 30, 2005
GRAFTON PLUS DBM PASTE
K042707
Osteotech, Inc.
Dental · 426d
Cleared Jul 29, 2005
DYNAGRAFT II DENTAL
K043573
Isotis Orthobiologics, Inc.
Dental · 214d
Cleared Apr 29, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K040501
Musculoskeletal Transplant Foundation
Dental · 428d

About Product Code NUN - Regulatory Context