510(k) · Cleared
ClearedURIS OMNI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truabutment, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 4, 2018 as substantially equivalent to K121995 (Osstem Implant Co., Ltd., 2012) and 7 other predicates after a 297-day review. Its family tree reaches back 14 generations to 1990. 7 later devices descend from it.
- Decided
- May 4, 2018
- Review
- 297 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 14 generations to K894595 (1990). 130 ancestors in all, the oldest K871863 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 2 generations backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK153521 IH Implant SystemSewonmedix, Inc. · 2016
- This deviceK172100 URIS OMNI SystemTruabutment, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK231411 INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243255 URIS Long Implant & AbutmentsTruabutment, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 4 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 3 generations backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- 2 generations backK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK153521 IH Implant SystemSewonmedix, Inc. · 2016
- This deviceK172100 URIS OMNI SystemTruabutment, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
- K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 3 generations on0descendants
- K243255URIS Long Implant & AbutmentsTruabutment, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −4 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −3 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| −2 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| −1 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| 0 (this device) | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +3 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +1 | K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 4 | 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? (8)
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 4…ondary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 05/04/2018 Predicate Device • Primary Predicate Device: - TS Fixture System (K121995) by Osstem Implant Co., Ltd. • Reference Devices: - CMI Implant IS II active (K120503) by Neobiotech Co., Ltd.… | 2012 |
| * | K120503 | Cmi Implant IS II ActiveSummary page 4…• Primary Predicate Device: - TS Fixture System (K121995) by Osstem Implant Co., Ltd. • Reference Devices: - CMI Implant IS II active (K120503) by Neobiotech Co., Ltd. - Oneplant Dental Implant System (K081748) by Warantec Co., Ltd. - IH Implant Sy… | 2012 |
| * | K081748 | Oneplant Dental Implant SystemSummary page 4…stem Implant Co., Ltd. • Reference Devices: - CMI Implant IS II active (K120503) by Neobiotech Co., Ltd. - Oneplant Dental Implant System (K081748) by Warantec Co., Ltd. - IH Implant System (K153521) by Sewon Medix Inc. - HU/HS/HG Prosthetic System(K08… | 2009 |
| * | K153521 | IH Implant SystemSummary page 4…CMI Implant IS II active (K120503) by Neobiotech Co., Ltd. - Oneplant Dental Implant System (K081748) by Warantec Co., Ltd. - IH Implant System (K153521) by Sewon Medix Inc. - HU/HS/HG Prosthetic System(K081575) by Osstem Implant Co., Ltd. - OSSTEM Implant S… | 2016 |
| * | K081575 | HU/HS/HG Prosthetic SystemSummary page 4…Oneplant Dental Implant System (K081748) by Warantec Co., Ltd. - IH Implant System (K153521) by Sewon Medix Inc. - HU/HS/HG Prosthetic System(K081575) by Osstem Implant Co., Ltd. - OSSTEM Implant System – Abutment (K161689) by Osstem Implant Co., Ltd. - T… | 2008 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 4…mplant System (K153521) by Sewon Medix Inc. - HU/HS/HG Prosthetic System(K081575) by Osstem Implant Co., Ltd. - OSSTEM Implant System – Abutment (K161689) by Osstem Implant Co., Ltd. - Transfer & Angled Abutment (K153015) by Osstem Implant Co., Ltd. - Strauma… | 2017 |
| * | K153015 | Transfer & Angled AbutmentSummary page 4…ystem(K081575) by Osstem Implant Co., Ltd. - OSSTEM Implant System – Abutment (K161689) by Osstem Implant Co., Ltd. - Transfer & Angled Abutment (K153015) by Osstem Implant Co., Ltd. - Straumann RC Temporary Abutments (K093027) by Straumann USA Device Description URIS O… | 2016 |
| * | K093027 | Straumann RC Temporary AbutmentsSummary page 4…ment (K161689) by Osstem Implant Co., Ltd. - Transfer & Angled Abutment (K153015) by Osstem Implant Co., Ltd. - Straumann RC Temporary Abutments (K093027) by Straumann USA Device Description URIS OMNI System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67… | 2010 |
What descends from it? (7)
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 9 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 130 ancestors have a recall of any class.
- Of its descendants, K200817 (Truabutment, Inc., 2020) has gone furthest, with 6 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. 2018, 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?
URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, 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.
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/K172100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172100: URIS OMNI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172100
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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