510(k) · Cleared
ClearedEK Implants and Abutments System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2022 as substantially equivalent to K140934 (Hiossen, Inc., 2014) and 5 other predicates after a 417-day review. Its family tree reaches back 15 generations to 1990. 7 later devices descend from it.
- Decided
- Jan 7, 2022
- Review
- 417 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K894595 (1990). 258 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253372 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing…Hiossen, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251427 EK Multi Angled 30 AbutmentHiossen, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243731 HEXIM Implant; Samwon General AbutmentsP&A USA · 2025
- Descendant · cites it directly · 0 of its ownK240232 EK D3.3 and Ultra Wide ImplantsHiossen, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 11 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 10 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 9 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 8 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 7 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 5 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 4 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · cites it directly2descendants
- K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc. · 2026 · cites it directly0descendants
- K251427EK Multi Angled 30 AbutmentHiossen, Inc. · 2026 · cites it directly0descendants
- K243731HEXIM Implant; Samwon General AbutmentsP&A USA · 2025 · 2 generations on0descendants
- K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −11 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −10 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −9 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −8 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −7 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −5 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −4 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −3 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| −2 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| −1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +1 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +1 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026 | — |
| +1 | K251427 | EK Multi Angled 30 Abutment | Hiossen, Inc. | 2026 | — |
| +2 | K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025 | — |
| +1 | K240232 | EK D3.3 and Ultra Wide Implants | Hiossen, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 11 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 17 | 0 |
| 2003 | 16 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 13 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | K140934 | Hiossen Implant SystemSummary page 4…cate Devices: Primary 510(k) Manufacturer(s) Hiossen Implant System K140934 Hiossen, Inc. Reference 510(k) Manufacturer E… | 2014 |
| * | K151626 | ET III Bio-SA Fixture SystemSummary page 4…Hiossen, Inc. Reference 510(k) Manufacturer ETIII Bio-SA Fixture System K151626 Hiossen, Inc. ETIII SA Fixture D3.2 K153332 Hiossen, Inc.… | 2016 |
| * | K182091 | Osstem Abutment SystemSummary page 4…Hiossen, Inc. ETIII SA Fixture D3.2 K153332 Hiossen, Inc. Osstem Abutment System K182091 Osstem Implant Co., Ltd. Osstem Implant System - Abutment K161689 Osstem Implant C… | 2019 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 4…sen, Inc. Osstem Abutment System K182091 Osstem Implant Co., Ltd. Osstem Implant System - Abutment K161689 Osstem Implant Co., Ltd. Hiossen Prosthetic System K140507 Osstem Implant C… | 2017 |
| * | K140507 | Hiossen Prosthetic SystemSummary page 4…Co., Ltd. Osstem Implant System - Abutment K161689 Osstem Implant Co., Ltd. Hiossen Prosthetic System K140507 Osstem Implant Co., Ltd. Prosthetic System K110308 Osstem Implant C… | 2014 |
| * | K110308 | Prosthetic SystemSummary page 4…Co., Ltd. Hiossen Prosthetic System K140507 Osstem Implant Co., Ltd. Prosthetic System K110308 Osstem Implant Co., Ltd. 6.4 Description of Device: The EK Dental Implants are intended to be surgically placed in t… | 2011 |
| † | K153332 | ETIII SA Fixture System (O3.2mm) | 2016 |
What descends from it? (7)
5 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 32 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 258 ancestors have a recall of any class.
- Of its descendants, K221866 (Newton Implant Systems, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K140934.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only. The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for…
Read the full statement (157 words)
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and
maxillae, in support of single or multiple-unit restorations including; cemented, screw or
overdenture restorations, and final or temporary abutment support for fixed bridgework. It is
indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount
and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in
mandibular and maxillary lateral and central incisor, in support of single or multiple-unit
restorations including; cemented retained, screw retained, or overdenture restorations, and final or
temporary abutment support for fixed bridgework. It is intended for delayed loading.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to
prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203360 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203360: EK Implants and Abutments System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203360
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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