# K070147: Intergro Oral

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i
- Decided: May 14, 2007 after 118 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GRAFTON DBM (Gel, Flex, Putty, Matrix, Crunch): named in the summary without a submission number

## Most influential descendants
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K113645: Regeneross Allograft Plus Minerlized (2012), 0 descendants of its own
- K082463: Progenix (2008), 0 descendants of its own

## Indications for use
InterGro® Oral 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/K070147
Methodology: https://510kreport.com/methodology
