510(k) Report

510(k) · Cleared

Cleared

Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio

K051443510(k) AbbreviatedCleared Jul 22, 200550-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Curasan Ag, Frankfurt Facility · LYC Bone Grafting Material, Synthetic

Cleared on Jul 22, 2005 as substantially equivalent to P800035 (Curasan AG, 1981) and 4 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1995. 18 later devices descend from it.

Decided
Jul 22, 2005
Review
50 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K941780 (1995). 17 ancestors in all, the oldest P800035 (1981). 18 later devices descend from it, 17 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1981: 1 other ancestor2000: 2 other ancestors1995: 3 other ancestors1993: 1 other ancestor1992: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2012: 4 descendants cleared2008: 1 descendant cleared2025: 1 descendant cleared2009: 2 descendants cleared2010: 5 descendants cleared2011: 2 descendants cleared2013: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant clearedK941780 · Orthovita Biogran · Orthovita Co. · 1995K962494 · Perioglas - Bioglass Bone Graft Particulate · Usbiomaterials Corp. · 1996K040278 · Perioglas-Bioglass Bone Graft Substitute · Novabone Products, LLC · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 9 other ancestors3 generations back: 1 other ancestor 1 generation forward: 17 descendants2 generations forward: 1 descendant K040278 · Perioglas-Bioglass Bone Graft Substitute · Novabone Products, LLC · 2004K962494 · Perioglas - Bioglass Bone Graft Particulate · Usbiomaterials Corp. · 1996K941780 · Orthovita Biogran · Orthovita Co. · 19950
  1. Root · 3 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
  2. 2 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
  3. 1 generation backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
  4. This deviceK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
  5. Descendant · cites it directly · 2 of its ownK053374 Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006
  6. Descendant · cites it directly · 1 of its ownK103709 Ceracell DentalCurasan AG · 2011
  7. Descendant · cites it directly · 1 of its ownK090950 Bone Plus BCPMegagen Implant Co., Ltd. · 2010
  8. Descendant · cites it directly · 1 of its ownK083372 Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
  9. Descendant · cites it directly · 1 of its ownK081561 Osferion DOlympus Terumo Biomaterials Corporation · 2008

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 22010: 52011: 22012: 42013: 12025: 1
2006high 5 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 18 · See all
  • K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006 · cites it directly2descendants
  • K103709Ceracell DentalCurasan AG · 2011 · cites it directly1descendant
  • K090950Bone Plus BCPMegagen Implant Co., Ltd. · 2010 · cites it directly1descendant
  • K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009 · cites it directly1descendant
  • K081561Osferion DOlympus Terumo Biomaterials Corporation · 2008 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K941780Orthovita BiogranOrthovita Co.1995—
−2K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp.1996—
−1K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC2004—
0 (this device)K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility2005—
+1K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG2006—
+1K103709Ceracell DentalCurasan AG2011—
+1K090950Bone Plus BCPMegagen Implant Co., Ltd.2010—
+1K083372Arrowbone-a, Arrowbone-BBrainbase Corporation2009—
+1K081561Osferion DOlympus Terumo Biomaterials Corporation2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198710
199210
199310
199530
199820
199910
200020
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200920
201050
201120
201240
201310
202510
FIG. 1 — Lineage of K051443, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*P800035Peri-Oss
Summary page 7
…ne Repair 9-1 3. PREDICATE DEVICES Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 BiO-OSS®, BIO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321 4.…
Curasan AG1981—
*K992416Perioglas- Bioglass Bone Graft Particulate
Summary page 7
…9-1 3. PREDICATE DEVICES Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 BiO-OSS®, BIO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321 4. INTENDED USE…
Usbiomaterials Corp.1999—
*K040278Perioglas-Bioglass Bone Graft Substitute
Summary page 7
…9-1 3. PREDICATE DEVICES Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 BiO-OSS®, BIO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321 4. INTENDED USE Cerasorb®…
Novabone Products, LLC2004—
*K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen
Summary page 7
…9-1 3. PREDICATE DEVICES Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 BiO-OSS®, BIO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321 4. INTENDED USE Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for:…
Geistlich-Pharma2004—
*K970321Bio-Oss Anorganic Bovine Bone
Summary page 7
…PREDICATE DEVICES Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 BiO-OSS®, BIO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321 4. INTENDED USE Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for: Augmentation or reconstructive trea…
Geistlich-Pharma1998—

Also cleared against P800035: 1 other device →

What descends from it? (18)

See all 18

17 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG20062
K103709Ceracell DentalCurasan AG20111
K090950Bone Plus BCPMegagen Implant Co., Ltd.20101
K083372Arrowbone-a, Arrowbone-BBrainbase Corporation20091
K081561Osferion DOlympus Terumo Biomaterials Corporation20081
K243745FG Bone Graft BFull Golden Biotech Corporation20250
K131385Easy-GraftDegradable Solutions AG20130
K111105Curasan Osseolive DentalCurasan AG20120
K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120
K120152Cerasorb PlusRiemser Arzneimittel AG20120

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 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • None of the 17 ancestors has a recall.
  • Of its descendants, K053374 (Ossacur AG, 2006) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate P800035.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

What is it indicated for?

Cerasorb® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy. - Filling of extraction sockets to enhance preservation of the alveolar ridge. - Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and…

Read the full statement (218 words)

Cerasorb® M DENTAL is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.

- Filling of infrabony periodontal defects.

- Filling of defects after root resection, apicoectomy, and cystectomy.

- Filling of extraction sockets to enhance preservation of the alveolar ridge.

- Elevation of the maxillary sinus floor.

- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cerasorb® DENTAL is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.

- Filling of infrabony periodontal defects.

- Filling of defects after root resection, apicoectomy, and cystectomy.

- Filling of extraction sockets to enhance preservation of the alveolar ridge.

- Elevation of the maxillary sinus floor.

- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

- Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cerasorb® Perio is recommended for:

- Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

- Filling of infrabony periodontal defects

- Filling of single-or multi-wall bone pockets.

- Filling of bifurcations and trifurcations

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against P800035

1 other device cites the same predicate.

  • K042583Calc-I-OssUltradent Products, Inc. · 2005

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K051443 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051443

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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