510(k) · Cleared
ClearedSM-Extra Wide (RBM) 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 14, 2008 as substantially equivalent to K063216 (Megagen Co., Ltd., 2007) after a 118-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 14, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010185 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK010185 6.0 X 5.7MM Dental ImplantBicon, Inc. · 2002
- 2 generations backK053353 Rescue Implant SystemMegagen Co., Ltd. · 2006
- 1 generation backK063216 Rescue Internal Implant SystemMegagen Co., Ltd. · 2007
- This deviceK080128 SM-Extra Wide (RBM) Implant SystemDio Department Dsi, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010185 | 6.0 X 5.7MM Dental Implant | Bicon, Inc. | 2002 | — |
| −2 | K053353 | Rescue Implant System | Megagen Co., Ltd. | 2006 | — |
| −1 | K063216 | Rescue Internal Implant System | Megagen Co., Ltd. | 2007 | — |
| 0 (this device) | K080128 | SM-Extra Wide (RBM) Implant System | Dio Department Dsi, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K063216 | Rescue Internal Implant SystemSummary page 1…ces panel Regulation Number: 21 CFR 872.3640 7. Predicate Devices Rescue Internal Dental Implant System (510(k) No.: k063216) 8. Performance Laboratory testing was conducted to determine device functionality and… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K063216.
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?
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or
mandivular molar areas for the purpose of providing prosthetic support for dental restoration
(Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures
can be used where smaller implants have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080128: SM-Extra Wide (RBM) 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/K080128
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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