510(k) · Cleared
ClearedSM Implant Systems
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 Sep 1, 2006 after a 67-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 31 later devices descend from it.
- Decided
- Sep 1, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
31 later devices descend from it, 4 citing it directly.
- This deviceK061797 SM Implant SystemsDio Department Dsi, Inc. · 2006
- Descendant · cites it directly · 25 of its ownK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- Descendant · 2 generations on · 20 of its ownK150344 Dentis Dental Implant SystemDentis Co., Ltd. · 2015
- Descendant · 2 generations on · 14 of its ownK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK192688 s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K073486Dentis Dental Implant SystemDentis Co., Ltd. · 2008 · cites it directly25descendants
- K150344Dentis Dental Implant SystemDentis Co., Ltd. · 2015 · 2 generations on20descendants
- K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016 · 2 generations on14descendants
- K171027Dentis Dental Implant SystemDentis Co., Ltd. · 2017 · 2 generations on5descendants
- K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061797 | SM Implant Systems | Dio Department Dsi, Inc. | 2006 | — |
| +1 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| +2 | K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015 | — |
| +2 | K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016 | — |
| +2 | K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017 | — |
| +3 | K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012087 | FDA’s K012087 is Cordis Palmaz Genesis Transhepatic Biliary Stent Our reading of the summary gave K012087, FDA’s number for Cordis Palmaz Genesis Transhepatic Biliary Stent (Cordis Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANKYLOS® DENTAL IMPLANT SYSTEM”. Kept off the family tree. | 2001 |
What descends from it? (31)
See all 314 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?
- Of its descendants, K073486 (Dentis Co., Ltd., 2008) has gone furthest, with 25 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.
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 SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061797: SM Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061797
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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