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. · DZL Screw, Fixation, Intraosseous
Cleared on May 7, 2019 as substantially equivalent to K160991 (Neobiotech Co., Ltd., 2017) and 1 other predicate after a 300-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- May 7, 2019
- Review
- 300 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K894595 (1990). 70 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- 1 generation backK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
- This deviceK181854 OssBuilder SystemOsstem Implant Co., Ltd. · 2019
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 3 generations backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK140600 SB AnchorOsstem Implant Co., Ltd. · 2014
- 1 generation backK172354 OssBuilder SystemOsstem Implant Co., Ltd. · 2018
- This deviceK181854 OssBuilder SystemOsstem Implant Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −3 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| −2 | K140600 | SB Anchor | Osstem Implant Co., Ltd. | 2014 | — |
| −1 | K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018 | — |
| 0 (this device) | K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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 |
|---|---|---|---|
| * | K160991 | Neo GBR SystemSummary page 4…: DZL - Subsequent Product Code : NHA 3. Predicate Device - Primary Predicate Neo GBR System, Neobiotech Co., Ltd. (K160991) - Reference Predicate OssBuilder System, OSSTEM Implant Co., Ltd. (K172354) QS-QI-505-7(Rev.0)… | 2017 |
| * | K172354 | OssBuilder SystemSummary page 4…e - Primary Predicate Neo GBR System, Neobiotech Co., Ltd. (K160991) - Reference Predicate OssBuilder System, OSSTEM Implant Co., Ltd. (K172354) QS-QI-505-7(Rev.0) -1/6- Letter(8.5 X 11in)… | 2018 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 70 ancestors have a recall of any class.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181854: 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/K181854
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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