510(k) · Cleared
ClearedCerasorb Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riemser Arzneimittel AG · NPM Bone Grafting Material, Animal Source
Cleared on Aug 13, 2012 as substantially equivalent to K051443 (Curasan Ag, Frankfurt Facility, 2005) after a 208-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 13, 2012
- Review
- 208 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941780 (1995). 18 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 3 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 2 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 1 generation backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- This deviceK120152 Cerasorb PlusRiemser Arzneimittel AG · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −3 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −2 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −1 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| 0 (this device) | K120152 | Cerasorb Plus | Riemser Arzneimittel 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 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 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 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 |
|---|---|---|---|
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 1…Special Controls Classification regulation Number: 21 CFR 872.3930 Product Code: LYC 3. PREDICATE DEVICES CERASORB® DENTAL: PMA80003 5/ K05 1443 Revised 2OJun 2012 6-2 CERASOR… | 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 17 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- None of the 18 ancestors has a recall.
- 16 other devices also cite its predicate K051443.
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. 2012, 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?
CERASORB® Plus is recommended for:
Defects after extirpation of bone cysts
Augmentation of the atrophied jaw ridge
Sinus lift or sinus base elevation respectively
Filling alveolar defects after tooth extraction for jaw ridge support
Filling extraction defects to create an implant site
Filling of two or multi-walled infrabony pockets, and bifurcation and triflurcation defects
Defects after operative removal of retained teeth or corrective osteotomes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120152: Cerasorb Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120152
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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