510(k) · Cleared
ClearedCurasan Osseolive 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 Dec 20, 2012 as substantially equivalent to K053387 (Novabone Products, LLC, 2006) and 2 other predicates after a 610-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Dec 20, 2012
- Review
- 610 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960978 (1996). 25 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 2 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 1 generation backK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- This deviceK111105 Curasan Osseolive DentalCurasan AG · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −2 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −1 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| 0 (this device) | K111105 | Curasan Osseolive Dental | Curasan AG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K053387 | Perioglas Bone Graft ParticulateSummary page 2…ified as follows: Device:................................... PerioGlas 510(k) Sponsor:....................... NovaBone Products, LLC 510(k) Number: ..................... K053387 Clearance Date: ....................... 14 February 2006 FDA Product Code:................... LYC Classification Name: ..........… | 2006 |
| * | K103709 | Ceracell DentalSummary page 2…........... 872.3930 Device:................................... CeracellO DENTAL 510(k) Sponsor:....................... Curasan AG 510(k) Number........................ K103709 Clearance Date:....................... 10 March 2011 FDA Product Code:................... LYC Classification Name: ..............… | 2011 |
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 3….................. 872.3930 Device:................................... Cerasorb® M DENTAL 510(k) Sponsor: .................Curasan AG 510(k) Number: .................. K051443 Clearance Date:....................... 22 July 2005 FDA Product Code:................... LYC Classification Name: ...............… | 2005 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 25 ancestors has a recall.
- 5 other devices also cite its predicate K053387.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.:
* Defects after the extirpation of bone cysts
* Augmentation of an atrophied alveolar ridge
* Sinus lift or sinus floor elevation (subantral augmentation)
* Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge
* Filling of extraction defects to create an implant bed
* Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects
* Defects after operative removal of retained teeth or corrective osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111105: Curasan Osseolive Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111105
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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