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NUN — Bone Grafting Material, Human Source Class II

FDA Device Classification

Classification Details

Product Code
NUN
Device Class
Class II
Regulation Number
872.3930
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130235hans biomedSURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTYJanuary 10, 2014
K113645biomet interpore crossREGENEROSS ALLOGRAFT PLUS MINERLIZEDJanuary 20, 2012
K103699exactechEACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCAugust 12, 2011
K091217musculoskeletal transplant foundationDBX DEMINERALIZED BONE MATRIX PUTTYOctober 2, 2009
K082463medtronic sofamor danekPROGENIXNovember 10, 2008
K081950medtronic sofamor danekPROGENIX PLUSJuly 18, 2008
K080462medtronic sofamor danekPROGENIX DBM PUTTYMay 13, 2008
K080418regeneration technologiesREGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPApril 30, 2008
K070147biomet 3iINTERGRO ORALMay 14, 2007
K060332isotisORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYMarch 29, 2006
K060306isotisACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYMarch 27, 2006
K051188osteotechGRAFTON DBMJanuary 3, 2006
K042707osteotechGRAFTON PLUS DBM PASTENovember 30, 2005
K043573isotis orthobiologicsDYNAGRAFT II DENTALJuly 29, 2005
K040501musculoskeletal transplant foundationDBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIXApril 29, 2005