510(k) · Cleared
ClearedOssBuilder 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 Mar 26, 2018 as substantially equivalent to K120951 (Osstem Implant Co., Ltd., 2012) and 1 other predicate after a 235-day review. Its family tree reaches back 11 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 26, 2018
- Review
- 235 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K894595 (1990). 30 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- This deviceK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK222451 Save GBRDentis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK192747 Yxoss CBR®Reoss GmbH · 2020
- Descendant · cites it directly · 0 of its ownK181854 OssBuilder SystemOsstem Implant Co., Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- This deviceK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −2 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| −1 | K140600 | SB Anchor | Osstem Implant Co., Ltd. | 2014 | — |
| 0 (this device) | K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018 | — |
| +1 | K222451 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +1 | K192747 | Yxoss CBR® | Reoss GmbH | 2020 | — |
| +1 | K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K120951 | Smartbuilder SystemSummary page 4…: JEY - Subsequent Product Code : NHA 3. Predicate Device - Primary Predicate SMARTbuilder System, OSSTEM IMPLANT Co., Ltd. (K120951) - Reference Devices SMARTBUILDER SYSTEM (SB1) (K130840) SB Anchor, OSSTEM Implant Co., Ltd. (K140600)… | 2012 |
| * | K140600 | SB AnchorSummary page 4…builder System, OSSTEM IMPLANT Co., Ltd. (K120951) - Reference Devices SMARTBUILDER SYSTEM (SB1) (K130840) SB Anchor, OSSTEM Implant Co., Ltd. (K140600) QS-QI-505-7(Rev.0) - 1/8- K172354 OSS… | 2014 |
| † | K130840 | Smartbuilder System (SB1) | 2013 |
What descends from it? (3)
3 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 28 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K222451 (Dentis Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2018, 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?
OssBuilder System is a metal device intended for use with a dental implant to stabilize
and support of bone graft in dento-alveolar bony defect sites.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172354: OssBuilder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172354
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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