510(k) · Cleared
ClearedImplantium II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 16, 2006 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) after a 112-day review. Its family tree reaches back 1 generation to 2004. 26 later devices descend from it.
- Decided
- Jun 16, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041368 (2004). 26 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK041368 Dentium CO., LTD. ImplantiumDentium Co., Ltd. · 2004 · Recalled
- This deviceK060501 Implantium IIDentium Co., Ltd. · 2006
- Descendant · cites it directly · 12 of its ownK122519 Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 2013
- Descendant · cites it directly · 9 of its ownK081748 Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009
- Descendant · 2 generations on · 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 · 2 generations on · 4 of its ownK170608 UF (II) Implant SystemDio Corporation · 2018
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K122519Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 2013 · cites it directly12descendants
- K081748Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009 · cites it directly9descendants
- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · 2 generations on7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
- K170608UF (II) Implant SystemDio Corporation · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041368 | Dentium CO., LTD. Implantium | Dentium Co., Ltd. | 2004 | 1 |
| 0 (this device) | K060501 | Implantium II | Dentium Co., Ltd. | 2006 | — |
| +1 | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | Dio Corporation | 2013 | — |
| +1 | K081748 | Oneplant Dental Implant System | Warantec Co., Ltd. | 2009 | — |
| +2 | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K170608 | UF (II) Implant System | Dio Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K041368 | Dentium CO., LTD. ImplantiumSummary page 1…y Name - Implantium II Common Name - Dental Implant Classification Name - Endosseous dental implant 3. Predicate Device: Implantium, Dentium Co., Ltd., K041368 4. Classifications Names & Citations: 21CFR 872.3640, DZE, Endosseous dental implant, Class2 5. Description: The… | 2004 |
What descends from it? (26)
See all 264 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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function.
Implantium II are for single stage or two stage surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060501: Implantium II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060501
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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