510(k) · Cleared
ClearedMBCP Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomatlante · LYC Bone Grafting Material, Synthetic
Cleared on Jun 2, 2006 as substantially equivalent to K051885 (Biomatlante, 2005) after a 74-day review. Its family tree reaches back 5 generations to 1999. 40 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990131 (1999). 6 ancestors in all. 40 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK051885 MBCPBiomatlante · 2005
- This deviceK060732 MBCP GelBiomatlante · 2006
- Descendant · cites it directly · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 3 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · cites it directly37descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 2 generations on12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 3 generations on7descendants
- K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K051885 | MBCP | Biomatlante | 2005 | — |
| 0 (this device) | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| +1 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K051885 | MBCPSummary page 2…ncipal component and intended use of MBCP Gel" is the same as previously cleared MBCP TM (K051885). MBCP GelW and the predicate devices are substantially equivalent… | 2005 |
What descends from it? (40)
See all 403 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080917 (Innovative Bioceramix, Inc., 2008) has gone furthest, with 37 descendants of its own.
- 13 other devices also cite its predicate K051885.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MBCP Gel T M is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP GeITM can generally be used for bone filling in closed cavities.
MBCP GeITM can be used with autogenous bone grafting materials.
Typical uses include but are not limited to:
* Periodontal/Infrabony defects
• Ridge augmentation
* Extraction sites (implant preparation/placement)
* Sinus lifts
* Cystic cavities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060732: MBCP Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060732
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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