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 Apr 11, 2008 as substantially equivalent to K070568 (Dio Department Dsi, Inc., 2007) after an 85-day review. Its family tree reaches back 2 generations to 2005. 7 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051018 (2005). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK051018 Intermezzo Implant SystemsMegagen Co., Ltd. · 2005
- 1 generation backK070568 Dio Protem Implant SystemDio Department Dsi, Inc. · 2007
- This deviceK080126 Dio Protem Implant SystemDio Department Dsi, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK112540 S-Mini Implant SystemNeobiotech Co., Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK181178 S-mini active FixtureNeobiotech Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK170394 Kisses MiniAchimhai Medical Corporation · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K112540S-Mini Implant SystemNeobiotech Co., Ltd. · 2012 · cites it directly5descendants
- K133050One Plus Implant SystemOsseofuse, Inc. · 2014 · 2 generations on1descendant
- K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024 · 2 generations on0descendants
- K181178S-mini active FixtureNeobiotech Co., Ltd. · 2018 · 2 generations on0descendants
- K170394Kisses MiniAchimhai Medical Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051018 | Intermezzo Implant Systems | Megagen Co., Ltd. | 2005 | — |
| −1 | K070568 | Dio Protem Implant System | Dio Department Dsi, Inc. | 2007 | — |
| 0 (this device) | K080126 | Dio Protem Implant System | Dio Department Dsi, Inc. | 2008 | — |
| +1 | K112540 | S-Mini Implant System | Neobiotech Co., Ltd. | 2012 | — |
| +2 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +2 | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024 | — |
| +2 | K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018 | — |
| +2 | K170394 | Kisses Mini | Achimhai Medical Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070568 | Dio Protem Implant SystemSummary page 3…(DIG Protei Implant (DIO Protemn Implant System) System(2.0/2.5mm)) K070568 The DIO Protein Implant… | 2007 |
What descends from it? (7)
2 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 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112540 (Neobiotech Co., Ltd., 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Protern 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/K080126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080126: Dio Protem Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080126
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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