NUNClass II
Bone Grafting Material, Human Source
21 CFR 872.3930 / Dental
NUN is the FDA product code for Bone Grafting Material, Human Source, a class II device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "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...". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NUN
- Device name
- Bone Grafting Material, Human Source
- FDA 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.
- Regulation
- 21 CFR 872.3930
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 15
- Ingested recalls
- 0
Clearances, product code NUN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 4 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
Applicants with the most clearances
Product code NUN| Applicant | Clearances |
|---|---|
| Medtronic Sofamor Danek | 3 |
| Isotis NV | 2 |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | 2 |
| Osteotech Inc | 2 |
| ZimVie US Corp LLC | 1 |
| Biomet Interpore Cross | 1 |
| Exactech, Inc. | 1 |
| Hans Biomed Corp. | 1 |
| IsoTis OrthoBiologics, Inc. | 1 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- ETEX Corporation
- Exactech, Inc.
- Hans Biomed Corp.
- HANSAmed Limited dba Citagenix
- Isomedix Operations Inc
- IsoTis OrthoBiologics, Inc.
- Keystone Dental Inc.
- LYNX Medical Pennsylvania
- Medtronic Engineering and Innovation Center (MEIC)
- Medtronic Sofamor Danek USA Inc
- Millstone Medical Outsourcing LLC
- Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
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