510(k) · Cleared
ClearedURIS OMNI Narrow System & Prosthetic
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 Oct 7, 2020 as substantially equivalent to K172100 (Truabutment, Inc., 2018) and 10 other predicates after a 191-day review. Its family tree reaches back 17 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 7, 2020
- Review
- 191 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 17 generations to K960026 (1996). 431 ancestors in all, the oldest K781060 (1978). 6 later devices descend from it, 5 citing it directly.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- This deviceK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK231411 INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · 2 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
- Descendant · cites it directly · 0 of its ownK230438 URIS Smart Path Implant System & ProstheticTruabutment, Inc. · 2023
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- This deviceK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd. · 2023 · cites it directly1descendant
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · cites it directly1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
- K243255URIS Long Implant & AbutmentsTruabutment, Inc. · 2025 · cites it directly0descendants
- K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −7 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −6 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −5 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −1 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| 0 (this device) | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +1 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +1 | K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025 | — |
| +1 | K230438 | URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 14 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 13 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 20 | 0 |
| 2003 | 19 | 0 |
| 2004 | 20 | 0 |
| 2005 | 18 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 28 | 0 |
| 2009 | 24 | 0 |
| 2010 | 19 | 0 |
| 2011 | 15 | 0 |
| 2012 | 15 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (11)
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 |
|---|---|---|---|
| * | K172100 | URIS OMNI SystemSummary page 4…ndary Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 10/06/2020 Predicate Device Primary Predicate Device: - URIS OMNI System (K172100) by TruAbutment Korea Co., Ltd. Reference Devices: - Nobel Active 3.0 (K102436) by Nobel Biocare. -… | 2018 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 4…ystem (K172100) by TruAbutment Korea Co., Ltd. Reference Devices: - Nobel Active 3.0 (K102436) by Nobel Biocare. - OSSTEM Implant System (K161689) by Osstem Implant Co., Ltd . - Hiossen Prosthetic System (K140507) by Osstem Implant Co., Ltd . - Osstem… | 2017 |
| * | K140507 | Hiossen Prosthetic SystemSummary page 4…- Nobel Active 3.0 (K102436) by Nobel Biocare. - OSSTEM Implant System (K161689) by Osstem Implant Co., Ltd . - Hiossen Prosthetic System (K140507) by Osstem Implant Co., Ltd . - Osstem Abutment System (K182091) by Osstem Implant Co., Ltd . - Multi Ang… | 2014 |
| * | K182091 | Osstem Abutment SystemSummary page 4…mplant System (K161689) by Osstem Implant Co., Ltd . - Hiossen Prosthetic System (K140507) by Osstem Implant Co., Ltd . - Osstem Abutment System (K182091) by Osstem Implant Co., Ltd . - Multi Angled Abutment (K123755) by Osstem Implant Co., Ltd . - SMART buil… | 2019 |
| * | K123755 | Multi Angled AbutmentSummary page 4…Prosthetic System (K140507) by Osstem Implant Co., Ltd . - Osstem Abutment System (K182091) by Osstem Implant Co., Ltd . - Multi Angled Abutment (K123755) by Osstem Implant Co., Ltd . - SMART builder System (K120951) by Osstem Implant Co., Ltd. - AnyOne Inter… | 2013 |
| * | K120951 | Smartbuilder SystemSummary page 4…tem Abutment System (K182091) by Osstem Implant Co., Ltd . - Multi Angled Abutment (K123755) by Osstem Implant Co., Ltd . - SMART builder System (K120951) by Osstem Implant Co., Ltd. - AnyOne Internal Implant System (K123988) by Megagen Implant Co., Ltd. - ET… | 2012 |
| * | K123988 | Anyonetm Internal Implant SystemSummary page 4…ed Abutment (K123755) by Osstem Implant Co., Ltd . - SMART builder System (K120951) by Osstem Implant Co., Ltd. - AnyOne Internal Implant System (K123988) by Megagen Implant Co., Ltd. - ET US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. - Preat… | 2013 |
| * | K160670 | ET US SS Prosthetic systemSummary page 4…ystem (K120951) by Osstem Implant Co., Ltd. - AnyOne Internal Implant System (K123988) by Megagen Implant Co., Ltd. - ET US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. - Preat Abutments (K183518) by Preat Corporation. - Oneplant Dental Implant… | 2017 |
| * | K081748 | Oneplant Dental Implant SystemSummary page 4…US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. - Preat Abutments (K183518) by Preat Corporation. - Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. - InCoris Zi (K123664) by Sirona Dental Systems GmbH. - RelyX Unicem 2Auto… | 2009 |
| * | K183106 | TruAbutment DSSummary page 4…mplant Co., Ltd. - InCoris Zi (K123664) by Sirona Dental Systems GmbH. - RelyX Unicem 2Automix (K100756) by 3M ESPE - TruAbutment DS (K183106) by TruAbutment Korea Co., Ltd. Page 1 of 24… | 2020 |
| * | K183518 | Preat AbutmentsSummary page 4…ernal Implant System (K123988) by Megagen Implant Co., Ltd. - ET US SS Prosthetic System (K160670) by Osstem Implant Co., Ltd. - Preat Abutments (K183518) by Preat Corporation. - Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. - InCoris… | 2019 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K123664 | Incoris ZI | 2013 |
| † | K100756 | MALTA | 2010 |
What descends from it? (6)
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 24 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 53 of the 431 ancestors have a recall of any class.
- Of its descendants, K231411 (Cowellmedi Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K172100.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors, 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 URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants…
Read the full statement (104 words)
URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors, 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 URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200817: URIS OMNI Narrow System & Prosthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200817
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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