510(k) · Cleared
ClearedInRoad® Dental Synthetic Bone Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteogene Tech Corp · LYC Bone Grafting Material, Synthetic
Cleared on Mar 4, 2022 as substantially equivalent to K102872 (Curasan AG, 2011) after a 535-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Mar 4, 2022
- Review
- 535 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K852742 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Coors Biomedical Co. · 1985
- 2 generations backK072056 Osteograf/D-700Dentsply International, Inc. · 2007
- 1 generation backK102872 Osbone DentalCurasan AG · 2011
- This deviceK202675 InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 | Coors Biomedical Co. | 1985 | — |
| −2 | K072056 | Osteograf/D-700 | Dentsply International, Inc. | 2007 | — |
| −1 | K102872 | Osbone Dental | Curasan AG | 2011 | — |
| 0 (this device) | K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K102872 | Osbone DentalSummary page 4…: 21 CFR 872.3930 Product Code: LYC III. PREDICATE DEVICE Predicate Device: Curasan, Osbone® Dental Synthetic Bone Graft, K102872 This predicate device has not been subject to a design-related recall. Reference Device: GENOSS, OSTEON III Synthetic Bone G… | 2011 |
| † | K153676 | Osteon Iii | 2016 |
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 37 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmenation) - Filling of alveolar defects following tooth extraction for alveolar ridge preservation - Filling of extraction defects to create an implant bed - Filling of two- or multi- walled…
Read the full statement (108 words)
InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as:
- Defects after removal of bone cysts
- Augmentation of the atrophied alveolar ridge
- Sinus lift and sinus floor elevation (subantral augmenation)
- Filling of alveolar defects following tooth extraction for alveolar ridge preservation
- Filling of extraction defects to create an implant bed
- Filling of two- or multi- walled infra-bony pockets. and bi- and trifurcation defects
- Support function for a membrane in controlled tissue regeneration (CTR)
- Defects after surgical removal of retained teeth or corrective osteotomies
- Other multi-walled bone defects of the alveolar processes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202675: InRoad® Dental Synthetic Bone Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202675
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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