510(k) · Cleared
ClearedSmartbuilder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · JEY Plate, Bone
Cleared on Oct 3, 2012 as substantially equivalent to K111761 (Neobiotech Co., Ltd., 2012) and 1 other predicate after a 187-day review. Its family tree reaches back 9 generations to 1990. 14 later devices descend from it.
- Decided
- Oct 3, 2012
- Review
- 187 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894595 (1990). 28 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- This deviceK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK231411 INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- This deviceK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
- K140600SB AnchorOsstem Implant Co., Ltd. · 2014 · cites it directly4descendants
- K172354OssBuilder SystemOsstem Implant Co., Ltd. · 2018 · cites it directly3descendants
- K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| 0 (this device) | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +1 | K140600 | SB Anchor | Osstem Implant Co., Ltd. | 2014 | — |
| +1 | K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018 | — |
| +2 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2023 | 5 | 0 |
| 2025 | 2 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 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 |
|---|---|---|---|
| * | K111761 | Neo Titanium Mesh, Cti-MemSummary page 1…Class HI JEY, NHA 3. Predicate Device: The Neo Titanium mesh, CTi-mem, Neobiotech Co., Ltd., KI 111761 The SQ IS SYSTEM, Neobiotech Co., Ltd., K090825 4. Description: Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder i… | 2012 |
| * | K090825 | SQ IS SystemSummary page 1…JEY, NHA 3. Predicate Device: The Neo Titanium mesh, CTi-mem, Neobiotech Co., Ltd., KI 111761 The SQ IS SYSTEM, Neobiotech Co., Ltd., K090825 4. Description: Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of tit… | 2009 |
What descends from it? (14)
See all 145 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 22 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K200817 (Truabutment, Inc., 2020) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K111761.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120951: Smartbuilder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120951
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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