510(k) · Cleared
ClearedDio UF Hsa Internal Sub-Merged Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Corporation · DZE Implant, Endosseous, Root-Form
Cleared on May 21, 2013 as substantially equivalent to K060501 (Dentium Co., Ltd., 2006) after a 277-day review. Its family tree reaches back 2 generations to 2004. 12 later devices descend from it.
- Decided
- May 21, 2013
- Review
- 277 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041368 (2004). 12 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK041368 Dentium CO., LTD. ImplantiumDentium Co., Ltd. · 2004 · Recalled
- 1 generation backK060501 Implantium IIDentium Co., Ltd. · 2006
- This deviceK122519 Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 2013
- Descendant · cites it directly · 4 of its ownK170608 UF (II) Implant SystemDio Corporation · 2018
- Descendant · cites it directly · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 1 of its ownK182194 UV Active Implant SystemDio Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK260006 INOSS SystemInosys, Inc. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170608UF (II) Implant SystemDio Corporation · 2018 · cites it directly4descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · cites it directly2descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K182194UV Active Implant SystemDio Corporation · 2018 · cites it directly1descendant
- K260006INOSS SystemInosys, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041368 | Dentium CO., LTD. Implantium | Dentium Co., Ltd. | 2004 | 1 |
| −1 | K060501 | Implantium II | Dentium Co., Ltd. | 2006 | — |
| 0 (this device) | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | Dio Corporation | 2013 | — |
| +1 | K170608 | UF (II) Implant System | Dio Corporation | 2018 | — |
| +1 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K182194 | UV Active Implant System | Dio Corporation | 2018 | — |
| +2 | K260006 | INOSS System | Inosys, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K060501 | Implantium IISummary page 1…t abutment 21 CER 872.3640 Classll DZE. NHA 6. Predicate Devices Implantium 11 (510(k) No: K060501) 7. Device Description The 010 UP HSA Internal Sub-Merged Implant System is comprised of denta… | 2006 |
What descends from it? (12)
See all 125 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 9 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K170608 (Dio Corporation, 2018) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K060501.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The DIO UP HSA Internal Sub-Merged Implant System is indicated for surgical placement in the upper and lower Jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller (03.8 - 05.5) implants can be placed with a conventional two stage, surgical process with an option for transmucosal healing or they can be placed in a single stage, surgical process for immediate…
Read the full statement (117 words)
The DIO UP HSA Internal Sub-Merged Implant System is indicated for surgical placement in the upper and lower Jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller (03.8 - 05.5) implants can be placed with a conventional two stage, surgical process with an option for transmucosal healing or they can be placed in a single stage, surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger (06.0 -- 07.0) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing, and are indicated for the molar region with delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122519: Dio UF Hsa Internal Sub-Merged 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/K122519
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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