Product Code: NUN FDA class 2 21 CFR 872.3930

Bone Grafting Material, Human Source

Dental

The Human Source Dental Bone Grafting Material is an implantable device derived from human bone intended to fill bony voids or gaps in dental, oral, and craniofacial/maxillofacial defects, including periodontal and infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, cystic defects, and craniofacial augmentation procedures. It is an FDA Class 2 implant regulated under 21 CFR 872.3930 in the Dental specialty, with product code NUN, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement in osseous defects. It does not carry life-sustaining support designation.

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510(k)s

FEI Numbers

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Basic Information

Product Code: NUN
Device Class: FDA class 2
Regulation Number: 872.3930
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130235	SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY	Jan 10, 2014	Substantially Equivalent	Hans Biomed Corp.
K113645	REGENEROSS ALLOGRAFT PLUS MINERLIZED	Jan 20, 2012	Substantially Equivalent	Biomet Interpore Cross
K103699	EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC	Aug 12, 2011	Substantially Equivalent	Exactech, Inc.
K091217	DBX DEMINERALIZED BONE MATRIX PUTTY	Oct 02, 2009	Substantially Equivalent	Musculoskeletal Transplant Foundation
K082463	PROGENIX	Nov 10, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K081950	PROGENIX PLUS	Jul 18, 2008	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K080462	PROGENIX DBM PUTTY	May 13, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K080418	REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST	Apr 30, 2008	Substantially Equivalent	Regeneration Technologies, Inc.
K070147	INTERGRO ORAL	May 14, 2007	Substantially Equivalent	Biomet 3i
K060332	ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY	Mar 29, 2006	Substantially Equivalent	Isotis NV
K060306	ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY	Mar 27, 2006	Substantially Equivalent	Isotis NV
K051188	GRAFTON DBM	Jan 03, 2006	Substantially Equivalent	Osteotech, Inc.
K042707	GRAFTON PLUS DBM PASTE	Nov 30, 2005	Substantially Equivalent	Osteotech, Inc.
K043573	DYNAGRAFT II DENTAL	Jul 29, 2005	Substantially Equivalent	Isotis Orthobiologics, Inc.
K040501	DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX	Apr 29, 2005	Substantially Equivalent	Musculoskeletal Transplant Foundation