510(k) · Cleared
ClearedIntermezzo Plus Fixture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 13, 2006 as substantially equivalent to K051018 (Megagen Co., Ltd., 2005) after a 132-day review. Its family tree reaches back 1 generation to 2005. 45 later devices descend from it.
- Decided
- Apr 13, 2006
- Review
- 132 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051018 (2005). 45 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK051018 Intermezzo Implant SystemsMegagen Co., Ltd. · 2005
- This deviceK053354 Intermezzo Plus FixtureMegagen Co., Ltd. · 2006
- Descendant · cites it directly · 43 of its ownK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 42 of its ownK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- Descendant · 3 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · 4 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K072959MS System (Denture)Osstem Implant Co., Ltd. · 2008 · cites it directly43descendants
- K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008 · 2 generations on42descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 3 generations on30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 4 generations on8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 4 generations on7descendants
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) | K053354 | Intermezzo Plus Fixture | Megagen Co., Ltd. | 2006 | — |
| +1 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| +3 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +4 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +4 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 1…21 CFR ~ 872.3640 Regulation Number: 872.3640 13-7. Predicate Devices Intermezzo Implant Systems (K051018) 13-8. Performance Laboratory testing was conducted to determine device function… | 2005 |
What descends from it? (45)
See all 452 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?
Intermezzo TM Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053354: Intermezzo Plus Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053354
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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