FDA product code NUN: Bone Grafting Material, Human Source
NUN is the FDA product code for bone grafting material, human source. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. FDA has cleared 15 510(k) submissions under NUN, from 11 different applicants. The average 510(k) review took 169 days (median 118).
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.
Classification
| Field | Value |
|---|---|
| Device name | Bone Grafting Material, Human Source |
| Device class | Class II |
| Regulation | 21 CFR 872.3930 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NUN clearance
Top NUN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Musculoskeletal Transplant Foundation | 2 | 2009-10-02 |
| Medtronic Sofamor Danek | 2 | 2008-11-10 |
| Isotis NV | 2 | 2006-03-29 |
| Osteotech, Inc. | 2 | 2006-01-03 |
| Hans Biomed Corp. | 1 | 2014-01-10 |
6 more applicants have NUN clearances. See the full list in Caduvo.
Most recent NUN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130235 | Hans Biomed Corp. | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | 2014-01-10 | 345 |
| K113645 | Biomet Interpore Cross | REGENEROSS ALLOGRAFT PLUS MINERLIZED | 2012-01-20 | 39 |
| K103699 | Exactech, Inc. | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | 2011-08-12 | 235 |
| K091217 | Musculoskeletal Transplant Foundation | DBX DEMINERALIZED BONE MATRIX PUTTY | 2009-10-02 | 158 |
| K082463 | Medtronic Sofamor Danek | PROGENIX | 2008-11-10 | 75 |
Recalls for NUN devices
openFDA lists no recalls for product code NUN.
Frequently asked questions
What is FDA product code NUN?
NUN is the FDA product code for bone grafting material, human source. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is NUN?
Class II, regulation 21 CFR 872.3930. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUN?
Across 15 cleared submissions the average was 169 days from receipt to decision (median 118).
Which companies have the most NUN clearances?
Musculoskeletal Transplant Foundation (2); Medtronic Sofamor Danek (2); Isotis NV (2); Osteotech, Inc. (2); Hans Biomed Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NUN
- Run a recall and safety report across every NUN manufacturer
- Watch product code NUN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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