510(k) · Cleared
ClearedDio Protem Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Department Dsi, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 25, 2007 as substantially equivalent to K051018 (Megagen Co., Ltd., 2005) after an 86-day review. Its family tree reaches back 1 generation to 2005. 8 later devices descend from it.
- Decided
- May 25, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051018 (2005). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK051018 Intermezzo Implant SystemsMegagen Co., Ltd. · 2005
- This deviceK070568 Dio Protem Implant SystemDio Department Dsi, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK080126 Dio Protem Implant SystemDio Department Dsi, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK112540 S-Mini Implant SystemNeobiotech Co., Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK181178 S-mini active FixtureNeobiotech Co., Ltd. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K080126Dio Protem Implant SystemDio Department Dsi, Inc. · 2008 · cites it directly7descendants
- K112540S-Mini Implant SystemNeobiotech Co., Ltd. · 2012 · 2 generations on5descendants
- K133050One Plus Implant SystemOsseofuse, Inc. · 2014 · 3 generations on1descendant
- K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024 · 3 generations on0descendants
- K181178S-mini active FixtureNeobiotech Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051018 | Intermezzo Implant Systems | Megagen Co., Ltd. | 2005 | — |
| 0 (this device) | K070568 | Dio Protem Implant System | Dio Department Dsi, Inc. | 2007 | — |
| +1 | K080126 | Dio Protem Implant System | Dio Department Dsi, Inc. | 2008 | — |
| +2 | K112540 | S-Mini Implant System | Neobiotech Co., Ltd. | 2012 | — |
| +3 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +3 | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024 | — |
| +3 | K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K051018 | Intermezzo Implant SystemsSummary page 3…LTD (Intermezzo FM Implant System) (DIO Protein Implant System) K051018 Immediate Provisional Implants… | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080126 | Dio Protem Implant System | 2008 | 7 |
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. 2007, 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 Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070568: Dio Protem 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/K070568
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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