510(k) · Cleared
ClearedIH Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sewonmedix, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 14, 2016 as substantially equivalent to K121995 (Osstem Implant Co., Ltd., 2012) and 3 other predicates after a 311-day review. Its family tree reaches back 13 generations to 1990. 10 later devices descend from it.
- Decided
- Oct 14, 2016
- Review
- 311 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 76 ancestors in all, the oldest K894844 (1990). 10 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 1 generation backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- This deviceK153521 IH Implant SystemSewonmedix, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK172100 URIS OMNI SystemTruabutment, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK231411 INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK222707 IH Implant SystemSewonmedix, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 9 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 8 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 7 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 6 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 1 generation backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- This deviceK153521 IH Implant SystemSewonmedix, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · cites it directly7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
- K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023 · 3 generations on1descendant
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 3 generations on1descendant
- K222707IH Implant SystemSewonmedix, Inc. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −9 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −8 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −7 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −6 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −3 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −2 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| −1 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| +1 | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +3 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023 | — |
| +3 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K222707 | IH Implant System | Sewonmedix, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K121995 | TS Fixture SystemSummary page 5…ical procedures. It is intended for delayed loading. Predicate Device: Substantial Equivalence Matrix (IH2 SLA Fixture) TS Fixture System, OSSTEM Implant Co., Ltd. K121995 - primary predicate Straumann® Bone Level Tapered Implant, Institut Straumann Ag, K140878… | 2012 |
| * | K140507 | Hiossen Prosthetic SystemSummary page 7…5 years 8 years - Substantial Equivalence Matrix (IH Prosthetic System) Hiossen Prosthetic System, OSSTEM Implant Co., Ltd., K140507 - primary predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 Healing Abutment, OSSTEM Implant Co., Ltd., K0… | 2014 |
| * | K123755 | Multi Angled AbutmentSummary page 7…nce Matrix (IH Prosthetic System) Hiossen Prosthetic System, OSSTEM Implant Co., Ltd., K140507 - primary predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 Healing Abutment, OSSTEM Implant Co., Ltd., K081575 Predicate devi… | 2013 |
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 7…System, OSSTEM Implant Co., Ltd., K140507 - primary predicate Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755 Healing Abutment, OSSTEM Implant Co., Ltd., K081575 Predicate devices IH Prosthetic System primary… | 2008 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
What descends from it? (10)
2 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 26 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 76 ancestors have a recall of any class.
- Of its descendants, K172100 (Truabutment, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 10 other devices also cite its predicate K121995.
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?
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153521: IH 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/K153521
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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