510(k) · Cleared
ClearedRegeneross Allograft Plus Minerlized
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Interpore Cross · NUN Bone Grafting Material, Human Source
Cleared on Jan 20, 2012 as substantially equivalent to K070147 (Biomet 3i, 2007) after a 39-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jan 20, 2012
- Review
- 39 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070147 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070147 Intergro OralBiomet 3i · 2007
- This deviceK113645 Regeneross Allograft Plus MinerlizedBiomet Interpore Cross · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070147 | Intergro Oral | Biomet 3i | 2007 | — |
| 0 (this device) | K113645 | Regeneross Allograft Plus Minerlized | Biomet Interpore Cross | 2012 | — |
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 |
|---|---|---|---|
| * | K070147 | Intergro OralSummary page 1…Cancellous Chips in aLipid Carrier Classification Name Class 11 Legally Marketed Devices to Which 510(k) K070147- lnterGro Oral Substantial Equivalence isClaimed Other Marketed Devices in the Same 510(k) K080428- Reg… | 2007 |
| † | K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters… | 2008 |
| † | K060332 | Orthoblast II DBM Demineralized Bone Matrix Paste and Putty | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K070147.
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. 2012, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113645: Regeneross Allograft Plus Minerlized.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113645
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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