# K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Apr 29, 2005 after 428 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 K970321 (1998). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 2.
- K003493: 3I Calcium Sodium Phosphate Bone Cement, Biomet, Inc. (2001) Summary page 2.
- K001148: Merogel Otologic Pack, Xomed, Inc. (2000) Summary page 2.

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

## Indications for use
DBX® Demineralized Bone Matrix is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including: Ridge augmentation Filling of cystic defects Sinus lifts Filling of extraction sites Craniofacial augmentation Filling of lesions of periodontal origin Filling of defects of endodontic origin Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fractures Filling resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. For dental applications, one or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site. DBX® is osteoconductive and has been shown to be osteoinductive in both validated animal models and a validated in vitro assay. DBX® has not been proven osteoinductive in a human model. DBX® is intended for single patient use only.

Source page: https://510kreport.com/device/K040501
Methodology: https://510kreport.com/methodology