510(k) · Cleared
ClearedReprobone Dental Grafting Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceramisys, Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Nov 3, 2011 as substantially equivalent to K033815 (Geistlich-Pharma, 2004) and 2 other predicates after a 308-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Nov 3, 2011
- Review
- 308 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K990131 (1999). 17 ancestors in all, the oldest K871773 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 6 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 5 generations backK032268 MBCPBiomatlante · 2003
- 4 generations backK043005 Modification to MBCPBiomatlante · 2005
- 3 generations backK051774 MBCPBiomatlante · 2006
- 2 generations backK073064 Graftys BCPGraftys · 2008
- 1 generation backK082286 BioactysGraftys · 2009
- This deviceK103820 Reprobone Dental Grafting MaterialCeramisys, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −6 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −5 | K032268 | MBCP | Biomatlante | 2003 | — |
| −4 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −3 | K051774 | MBCP | Biomatlante | 2006 | — |
| −2 | K073064 | Graftys BCP | Graftys | 2008 | — |
| −1 | K082286 | Bioactys | Graftys | 2009 | — |
| 0 (this device) | K103820 | Reprobone Dental Grafting Material | Ceramisys, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenSummary page 1…vice panel: Oral/Dental 3. Legally Marketed Predicate'Device The subject device is substantially equivalent to previously cleared devices. Bio-Oss® Granules (K0338 15) Bioactys® (K082286) MBCP® (K051885) 4. Device Description ReproBone'8 is a sterile, single-use, resorbable bone void filler. Re… | 2004 |
| * | K082286 | BioactysSummary page 1…Oral/Dental 3. Legally Marketed Predicate'Device The subject device is substantially equivalent to previously cleared devices. Bio-Oss® Granules (K0338 15) Bioactys® (K082286) MBCP® (K051885) 4. Device Description ReproBone'8 is a sterile, single-use, resorbable bone void filler. ReproBonee is a microp… | 2009 |
| * | K051885 | MBCPSummary page 1…. Legally Marketed Predicate'Device The subject device is substantially equivalent to previously cleared devices. Bio-Oss® Granules (K0338 15) Bioactys® (K082286) MBCP® (K051885) 4. Device Description ReproBone'8 is a sterile, single-use, resorbable bone void filler. ReproBonee is a microporous and macrop… | 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 12 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 17 ancestors has a recall.
- 17 other devices also cite its predicate K033815.
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?
ReproBone 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103820: Reprobone Dental Grafting Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103820
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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