# K113645: Regeneross Allograft Plus Minerlized

- Pathway: 510(k) (Special)
- Applicant: Biomet Interpore Cross
- Decided: Jan 20, 2012 after 39 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070147 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070147: Intergro Oral, Biomet 3i (2007) Summary page 1.

## Indications for use
RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Source page: https://510kreport.com/device/K113645
Methodology: https://510kreport.com/methodology