510(k) · Cleared
ClearedIntergro Oral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i · NUN Bone Grafting Material, Human Source
Cleared on May 14, 2007 after a 118-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 14, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK070147 Intergro OralBiomet 3i · 2007
- 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 · cites it directly · 0 of its ownK113645 Regeneross Allograft Plus MinerlizedBiomet Interpore Cross · 2012
- Descendant · 2 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
Most influential descendants
Showing 4 of 4 · See all- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · cites it directly2descendants
- K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 2 generations on1descendant
- K113645Regeneross Allograft Plus MinerlizedBiomet Interpore Cross · 2012 · cites it directly0descendants
- K082463ProgenixMedtronic Sofamor Danek · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070147 | Intergro Oral | Biomet 3i | 2007 | — |
| +1 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +1 | K113645 | Regeneross Allograft Plus Minerlized | Biomet Interpore Cross | 2012 | — |
| +2 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2012 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | — | GRAFTON DBM (Gel, Flex, Putty, Matrix, Crunch) Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K080462 (Medtronic Sofamor Danek, 2008) has gone furthest, with 2 descendants of its own.
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. 2007, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070147: Intergro Oral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070147
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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