510(k) · Cleared
ClearedIU Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warantec Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2018 as substantially equivalent to K123155 (Shinhung Mst Co., Ltd., 2013) after a 320-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 18, 2018
- Review
- 320 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931767 (1994). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 2 generations backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- 1 generation backK123155 Luna Dental Implant SystemShinhung Mst Co., Ltd. · 2013
- This deviceK172345 IU Implant SystemWarantec Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221969 IU Implant System AbutmentWarantec Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −2 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| −1 | K123155 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2013 | — |
| 0 (this device) | K172345 | IU Implant System | Warantec Co., Ltd. | 2018 | — |
| +1 | K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023 | — |
| +1 | K221969 | IU Implant System Abutment | Warantec Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123155 | Luna Dental Implant SystemSummary page 5…Class II g) Panel : Dental III. PREDICATE DEVICE a) Primary Predicate Device: Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155 b) Reference Device: SuperLine / DENTIUM CO., LTD. / K160965 AnyOneTM Internal Implant System / MegaGenImplant Co… | 2013 |
| † | K160965 | SuperLine | 2017 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K141457 | Dentium Implantium and Superline Abutments | 2014 |
| † | K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 |
What descends from it? (2)
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 24 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K221972 (Warantec Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K123155.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172345: IU 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/K172345
Report an extraction error
Are you the manufacturer?
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