510(k) · Cleared
ClearedSynthetic Bone Graft Particulate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dazhou Medical Technology Co., Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Feb 21, 2025 as substantially equivalent to K040278 (Novabone Products, LLC, 2004) after a 298-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 21, 2025
- Review
- 298 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941780 (1995). 9 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 2 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 1 generation backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- This deviceK241186 Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −2 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −1 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| 0 (this device) | K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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 |
|---|---|---|---|
| * | K040278 | Perioglas-Bioglass Bone Graft SubstituteSummary page 5…duct Code: LYC 3. Predicate Device(s) Product Name: PerioGlas - Bioglass Bone Graft Particulate (K040278) Common or Usual Name: Bone grafting material Regulation Number: 21 CFR 872.3930 Product Code:… | 2004 |
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 30 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 9 ancestors has a recall.
- 11 other devices also cite its predicate K040278.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241186: Synthetic Bone Graft Particulate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241186
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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