510(k) · Cleared
ClearedRegenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset IC, Rti Allograft Past
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regeneration Technologies, Inc. · NUN Bone Grafting Material, Human Source
Cleared on Apr 30, 2008 after a 75-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 30, 2008
- Review
- 75 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (6)
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 PLUS® DBM Paste Named without a submission number | |
| * | — | Grafton® DBM Named without a submission number | |
| * | — | Accell Connexus Named without a submission number | |
| * | — | DBX® Demineralized Bone Matrix Named without a submission number | |
| * | — | RTI Allograft Paste Named without a submission number | |
| * | — | RTI Allograft Paste IC Named without a submission number |
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.
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. 2008, 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?
These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including * Periodontal defects; · Alveolar ridge augmentation; · Extraction sockets (ridge preservation, implant preparation/ placement); · Maxillary sinus floor elevation; · Craniofacial…
Read the full statement (99 words)
These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including
* Periodontal defects;
· Alveolar ridge augmentation;
· Extraction sockets (ridge preservation, implant preparation/ placement);
· Maxillary sinus floor elevation;
· Craniofacial augmentation;
· Root resection, apicoectomy and cystectomy;
* Tumor resection.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080418: Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset IC, Rti Allograft Past.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080418
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026