510(k) · Cleared
ClearedOsbone Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curasan AG · LYC Bone Grafting Material, Synthetic
Cleared on Jan 12, 2011 as substantially equivalent to K873763 (Geistlich-Pharma, 1987) and 2 other predicates after a 104-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Jan 12, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K852742 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Coors Biomedical Co. · 1985
- 1 generation backK072056 Osteograf/D-700Dentsply International, Inc. · 2007
- This deviceK102872 Osbone DentalCurasan AG · 2011
- Descendant · cites it directly · 0 of its ownK202675 InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp · 2022
Most influential descendants
Showing 1 of 1 · See all- K202675InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 | Coors Biomedical Co. | 1985 | — |
| −1 | K072056 | Osteograf/D-700 | Dentsply International, Inc. | 2007 | — |
| 0 (this device) | K102872 | Osbone Dental | Curasan AG | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K873763 | Bio-Oss - Ceramic Pure Natural HydroxyapatiteSummary page 1…id filler Classification Name: Bone grafting material, synthetic 3. PREDICATE DEVICES * BIO-OSS -Ceramic Pure Natural Hydroxyapatite (Geistlich-Pharma, K873763) " Endobon (BIOMET, Inc., K980679) " OsteoGraf/D (DentSply, K072056) 4. DEVICE DESCRIPTION Osbone® DENTAL is an open-cell… | 1987 |
| * | K980679 | EndobonSummary page 1…Bone grafting material, synthetic 3. PREDICATE DEVICES * BIO-OSS -Ceramic Pure Natural Hydroxyapatite (Geistlich-Pharma, K873763) " Endobon (BIOMET, Inc., K980679) " OsteoGraf/D (DentSply, K072056) 4. DEVICE DESCRIPTION Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone… | 1998 |
| * | K072056 | Osteograf/D-700Summary page 1…thetic 3. PREDICATE DEVICES * BIO-OSS -Ceramic Pure Natural Hydroxyapatite (Geistlich-Pharma, K873763) " Endobon (BIOMET, Inc., K980679) " OsteoGraf/D (DentSply, K072056) 4. DEVICE DESCRIPTION Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone regeneration. It is comprised of a… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202675 | InRoad® Dental Synthetic Bone Graft | 2022 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 21.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K202675 (Osteogene Tech Corp, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:
Defects after removal of bone cysts
Augmentation of the atrophied alveolar ridge
Sinus lift and sinus floor elevation (subantral augmentation)
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 infrabony 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/K102872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102872: Osbone Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102872
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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