510(k) · Cleared
ClearedPolybone Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyung Won Medical Co., Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Jun 16, 2010 as substantially equivalent to K053374 (Ossacur AG, 2006) and 1 other predicate after a 330-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 16, 2010
- Review
- 330 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941780 (1995). 19 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 4 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 3 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 2 generations backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- 1 generation backK053374 Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006
- This deviceK092194 Polybone DentalKyung Won Medical Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −4 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −3 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −2 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| −1 | K053374 | Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM) | Ossacur AG | 2006 | — |
| 0 (this device) | K092194 | Polybone Dental | Kyung Won Medical Co., Ltd. | 2010 | — |
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 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? (2)
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 |
|---|---|---|---|
| * | K053374 | Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Summary page 1…Classification Name: Bone Grafting Material, Synthetic Classification regulation: 21CFR872.3930 2. Predicate Device: OSSAPLAST TmDENTAL(K053374) / Cerasorb® M Dental(K05 1443) 3. Description: PolyBone® ~Dental is a synthetic resorbable calcium phosphate bon… | 2006 |
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 1…Bone Grafting Material, Synthetic Classification regulation: 21CFR872.3930 2. Predicate Device: OSSAPLAST TmDENTAL(K053374) / Cerasorb® M Dental(K05 1443) 3. Description: PolyBone® ~Dental is a synthetic resorbable calcium phosphate bone grafting material w… | 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 15 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 19 ancestors has a recall.
- 1 other device also cites its predicate K053374.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction…
Read the full statement (115 words)
PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts.
PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092194: Polybone Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092194
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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