510(k) · Cleared
ClearedHero II Dental Implant System, UI Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimecca Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 21, 2013 as substantially equivalent to K121047 (Kj Meditech Co., Ltd., 2012) and 1 other predicate after a 51-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Mar 21, 2013
- Review
- 51 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894595 (1990). 39 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK072896 GS Fixture SystemOsstem Implant Co., Ltd. · 2007
- 1 generation backK121047 Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd. · 2012
- This deviceK130221 Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd. · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK072896 GS Fixture SystemOsstem Implant Co., Ltd. · 2007
- 1 generation backK121047 Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd. · 2012
- This deviceK130221 Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K072896 | GS Fixture System | Osstem Implant Co., Ltd. | 2007 | — |
| −1 | K121047 | Hero II Dental Implant System, IS Dental Implant System | Kj Meditech Co., Ltd. | 2012 | — |
| 0 (this device) | K130221 | Hero II Dental Implant System, UI Dental Implant System | Medimecca Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K121047 | Hero II Dental Implant System, IS Dental Implant SystemSummary page 1…Product Code: DZE, NHA Classification regulation: 21CFR872.3640 4. Predicate Device: HERO 11 and IS Dental Implant System (K12 1047) Osseofuse implant system (KI 10577) 510(k) Submission. 510(k)… | 2012 |
| * | K110577 | Osseofuse Dental Implant System | 2011 |
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 23 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 39 ancestors have a recall of any class.
- 6 other devices also cite its predicate K121047.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Hero 11 Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edlentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero 11 Denial Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130221: Hero II Dental Implant System, UI Dental 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/K130221
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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