510(k) · Cleared
ClearedRegenomer® Syringe, Regenomer® Plug, Regenomer® Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nibec Co., Ltd. · NPM Bone Grafting Material, Animal Source
Cleared on Dec 10, 2015 as substantially equivalent to K040783 (Terumo Corp., 2004) after a 329-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Dec 10, 2015
- Review
- 329 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974399 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 NPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NPM device
- #1 K240661 Geistlich Bio-Oss®score 15.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K040783 | FoundationSummary page 4…l Classification Name: Bone grafting material Predicate devices Primary predicate FOUNDATION Bone Filling Augmentation Material (K040783) Manufactured by: Terumo Corporation 44-1, 2 chome Hatagaya, Shibuya-ku Tokyo 151-0072… | 2004 |
| † | K092428 | Bio-Oss Collagen | 2010 |
| † | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | 2004 |
| † | K974399 | Bio-Oss Collagen | 1998 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K040783.
How does its category compare?
All NPM devicesNPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NPM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPM
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPM
14in 2025
MAUDE reports naming product code NPM, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 3 | 112 | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 4 | 349 | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 5 | 191 | 0 | 3 |
| 2018 | 2 | — | 1 | 8 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 3 | 231 | 3 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 27 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 3 | 211 | 0 | 5 |
| 2025 | 3 | 30 | 0 | 14 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table. Format: Syringe — Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR); filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Format: Plug —…
Read the full statement (99 words)
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect.
The indication for use depending on the device format is further classified as described in following table.
Format: Syringe — Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR); filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Format: Plug — Filling of extraction sockets; augmentation or reconstructive treatment of the alveolar ridge; elevation of maxillary sinus floor.
Format: Block — Augmentation or reconstructive treatment of the alveolar ridge; elevation of maxillary sinus floor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150079: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150079
Report an extraction error
Are you the manufacturer?
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