510(k) · Cleared
ClearedDBX Demineralized Bone Matrix Putty, Paste and Mix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · NUN Bone Grafting Material, Human Source
Cleared on Apr 29, 2005 as substantially equivalent to K970321 (Geistlich-Pharma, 1998) and 2 other predicates after a 428-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Apr 29, 2005
- Review
- 428 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K970321 (1998). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970321 Bio-Oss Anorganic Bovine BoneGeistlich-Pharma · 1998
- This deviceK040501 DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation · 2005
- Descendant · cites it directly · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970321 | Bio-Oss Anorganic Bovine Bone | Geistlich-Pharma | 1998 | — |
| 0 (this device) | K040501 | DBX Demineralized Bone Matrix Putty, Paste and Mix | Musculoskeletal Transplant Foundation | 2005 | — |
| +1 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +2 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970321 | Bio-Oss Anorganic Bovine BoneSummary page 2…l, will correlate with clinical performance in human subjects. PREDICATE DEVICES: DBX® is substantially equivalent to Geistlich-Pharma's Bio-Oss Anorganic Bovine Bone (K970321), Bioinet's 3i Calcium Sodium Phosphate Bone Cement (K003493) and Xomed's Merogel (K001148). Mir C… | 1998 |
| * | K003493 | 3I Calcium Sodium Phosphate Bone CementSummary page 2…. PREDICATE DEVICES: DBX® is substantially equivalent to Geistlich-Pharma's Bio-Oss Anorganic Bovine Bone (K970321), Bioinet's 3i Calcium Sodium Phosphate Bone Cement (K003493) and Xomed's Merogel (K001148). Mir CONFIDENTIAL Page 323 of 326 === Page… | 2001 |
| * | K001148 | Merogel Otologic PackSummary page 2…substantially equivalent to Geistlich-Pharma's Bio-Oss Anorganic Bovine Bone (K970321), Bioinet's 3i Calcium Sodium Phosphate Bone Cement (K003493) and Xomed's Merogel (K001148). Mir CONFIDENTIAL Page 323 of 326 DEPARTMENT OF HEALTH &… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080462 | Progenix DBM Putty | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NUN devicesNUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NUN
75in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUN
No recall names NUN since 2007.
Adverse event reports per year · NUN
6in 2025
MAUDE reports naming product code NUN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 75 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (151 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040501
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026