510(k) · Cleared
ClearedUD 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 Dec 5, 2013 as substantially equivalent to K121047 (Kj Meditech Co., Ltd., 2012) after a 178-day review. Its family tree reaches back 9 generations to 1990. 5 later devices descend from it.
- Decided
- Dec 5, 2013
- Review
- 178 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 19 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- 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 deviceK131682 UD Implant SystemMedimecca Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK160536 Chaorum Implant SystemMedimecca Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK231932 TDS (Techwin Dental System)Techwin Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK211978 JplantJj Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202039 Honorst Implant SystemMedimecca Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK173570 SD AbutmentSurgident Co., Ltd. · 2019
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 deviceK131682 UD Implant SystemMedimecca Co., Ltd. · 2013
Most influential descendants
Showing 5 of 5 · See all- K160536Chaorum Implant SystemMedimecca Co., Ltd. · 2017 · cites it directly3descendants
- K231932TDS (Techwin Dental System)Techwin Co., Ltd. · 2024 · 2 generations on0descendants
- K211978JplantJj Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K202039Honorst Implant SystemMedimecca Co., Ltd. · 2020 · 2 generations on0descendants
- K173570SD AbutmentSurgident Co., Ltd. · 2019 · cites it directly0descendants
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) | K131682 | UD Implant System | Medimecca Co., Ltd. | 2013 | — |
| +1 | K160536 | Chaorum Implant System | Medimecca Co., Ltd. | 2017 | — |
| +2 | K231932 | TDS (Techwin Dental System) | Techwin Co., Ltd. | 2024 | — |
| +2 | K211978 | Jplant | Jj Medical Co., Ltd. | 2022 | — |
| +2 | K202039 | Honorst Implant System | Medimecca Co., Ltd. | 2020 | — |
| +1 | K173570 | SD Abutment | Surgident Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K121047 | Hero II Dental Implant System, IS Dental Implant SystemSummary page 1…2.3640 Class 1I 4. Predicate Device: Hero 11and IS Dental Implant System by KJ Meditech Co.. Ltd. (K 121047) 5. Description: UD Implant System is a dental implant system made of titanium (Fixture: ASTM F 136/… | 2012 |
What descends from it? (5)
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 23 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K160536 (Medimecca Co., Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 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?
UID Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, oraoverdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131682: UD 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/K131682
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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