NUN — Bone Grafting Material, Human Source Class II
FDA product code NUN covers "Bone Grafting Material, Human Source", a Class II medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 15 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130235 | hans biomed | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | January 10, 2014 |
| K113645 | biomet interpore cross | REGENEROSS ALLOGRAFT PLUS MINERLIZED | January 20, 2012 |
| K103699 | exactech | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | August 12, 2011 |
| K091217 | musculoskeletal transplant foundation | DBX DEMINERALIZED BONE MATRIX PUTTY | October 2, 2009 |
| K082463 | medtronic sofamor danek | PROGENIX | November 10, 2008 |
| K081950 | medtronic sofamor danek | PROGENIX PLUS | July 18, 2008 |
| K080462 | medtronic sofamor danek | PROGENIX DBM PUTTY | May 13, 2008 |
| K080418 | regeneration technologies | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIP | April 30, 2008 |
| K070147 | biomet 3i | INTERGRO ORAL | May 14, 2007 |
| K060332 | isotis | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | March 29, 2006 |
| K060306 | isotis | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | March 27, 2006 |
| K051188 | osteotech | GRAFTON DBM | January 3, 2006 |
| K042707 | osteotech | GRAFTON PLUS DBM PASTE | November 30, 2005 |
| K043573 | isotis orthobiologics | DYNAGRAFT II DENTAL | July 29, 2005 |
| K040501 | musculoskeletal transplant foundation | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | April 29, 2005 |