510(k) · Cleared
ClearedOSSTEM Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 17, 2016 after a 129-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Oct 17, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK161604 OSSTEM Implant SystemOsstem Implant Co., Ltd. · 2016
- Descendant · cites it directly · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK233194 TS Abutment SystemOsstem Implant Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK222778 Osstem Implant SystemOsstem Implant Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK242753 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · cites it directly8descendants
- K233194TS Abutment SystemOsstem Implant Co., Ltd. · 2024 · cites it directly2descendants
- K222778Osstem Implant SystemOsstem Implant Co., Ltd. · 2023 · cites it directly2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 2 generations on1descendant
- K242753SD TL Implant SystemArum Dentistry Co., Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | 2016 | — |
| +1 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024 | — |
| +1 | K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023 | — |
| +2 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 153 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?
- Of its descendants, K211090 (Izenimplant Co., Ltd., 2022) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Fixture System is intended to be used in the molar region.
Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.
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/K161604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161604: OSSTEM Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161604
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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