510(k) · Cleared
ClearedOneplant Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warantec Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 27, 2009 as substantially equivalent to K070228 (Dentium Co., Ltd., 2007) and 5 other predicates after a 281-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 281 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K944964 (1995). 59 ancestors in all, the oldest K871863 (1987). 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 2 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 1 generation backK052823 Implantium AbutmentsDentium, Inc. · 2006
- This deviceK081748 Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009
- Descendant · cites it directly · 7 of its ownK172100 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 · 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · cites it directly7descendants
- 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 · cites it directly1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −2 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K052823 | Implantium Abutments | Dentium, Inc. | 2006 | — |
| 0 (this device) | K081748 | Oneplant Dental Implant System | Warantec Co., Ltd. | 2009 | — |
| +1 | 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 | — |
| +1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 10 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K070228 | Implantium ProstheticsSummary page 1…ous NHA; Class II per regulations 872.3640 and 872.3630 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices… | 2007 |
| * | K052957 | Implantium ProstheticsSummary page 1…Class II per regulations 872.3640 and 872.3630 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices made of a… | 2006 |
| * | K060501 | Implantium IISummary page 1…per regulations 872.3640 and 872.3630 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices made of a material… | 2006 |
| * | K052823 | Implantium AbutmentsSummary page 1…ations 872.3640 and 872.3630 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices made of a material such as… | 2006 |
| * | K041368 | Dentium CO., LTD. ImplantiumSummary page 1…2.3640 and 872.3630 4. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices made of a material such as tita… | 2004 |
| * | K051576 | Avana Dental Implant SystemSummary page 1…The legally marketed device to which we are claiming equivalence [807.92(a)(3)] DENTIUM Multiple: K070228; K052957; K060501; K052823; K041368, Osstem Implant K051576 5. Description of device: Dental implant systems are devices made of a material such as titanium intended to be surgicall… | 2005 |
What descends from it? (9)
4 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 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 59 ancestors have a recall of any class.
- Of its descendants, K172100 (Truabutment, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K070228.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081748: Oneplant Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081748
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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