510(k) · Cleared
ClearedSmartbuilder System (SB1)
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 Sep 18, 2013 as substantially equivalent to K120951 (Osstem Implant Co., Ltd., 2012) after a 175-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Sep 18, 2013
- Review
- 175 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- This deviceK130840 Smartbuilder System (SB1)Osstem Implant Co., Ltd. · 2013
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 6 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 5 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 4 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- This deviceK130840 Smartbuilder System (SB1)Osstem Implant Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −6 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −5 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −4 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −3 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −1 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K130840 | Smartbuilder System (SB1) | Osstem Implant Co., Ltd. | 2013 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K120951 | Smartbuilder SystemSummary page 1…Class II JEY 3. Predicate Device: The SMARThuilder System, OSSTEM IMPLANT Co., Ltd., K120951 4. Description: Customized 3D Pre-Formed Titanium Membrane. SMARThuilder System (SB 1) is the non- absorbable membrane th… | 2012 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
- 4 other devices also cite its predicate K120951.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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/K130840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130840: Smartbuilder System (SB1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130840
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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