510(k) · Cleared
ClearedLuna Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shinhung Mst Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 31, 2013 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) and 1 other predicate after a 387-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Oct 31, 2013
- Review
- 387 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931767 (1994). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 1 generation backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- This deviceK123155 Luna Dental Implant SystemShinhung Mst Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK172345 IU Implant SystemWarantec Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221752 StellaShinhung Mst Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK221969 IU Implant System AbutmentWarantec Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223395 Luna Dental Implant SystemShinhung Mst Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172345IU Implant SystemWarantec Co., Ltd. · 2018 · cites it directly2descendants
- K221972Warantec Custom AbutmentWarantec Co., Ltd. · 2023 · 2 generations on0descendants
- K221752StellaShinhung Mst Co., Ltd. · 2023 · cites it directly0descendants
- K221969IU Implant System AbutmentWarantec Co., Ltd. · 2023 · 2 generations on0descendants
- K223395Luna Dental Implant SystemShinhung Mst Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −1 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| 0 (this device) | K123155 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2013 | — |
| +1 | K172345 | IU Implant System | Warantec Co., Ltd. | 2018 | — |
| +2 | K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023 | — |
| +1 | K221752 | Stella | Shinhung Mst Co., Ltd. | 2023 | — |
| +2 | K221969 | IU Implant System Abutment | Warantec Co., Ltd. | 2023 | — |
| +1 | K223395 | Luna Dental Implant System | Shinhung Mst 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 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 |
|---|---|---|---|
| * | K041368 | Dentium CO., LTD. ImplantiumSummary page 1…tem Common Names :Endosseous Dental Implant Classification Name :Implant, Endosseous, Root-Form 3. Predicate Device: 3.1 Dentium Implantium (K041368) Manufactured by Dentium Co., Ltd OCT 3 1 2013 3.2 Implantium Prosthetics(K052957) Manufactured… | 2004 |
| * | K052957 | Implantium ProstheticsSummary page 1…-Form 3. Predicate Device: 3.1 Dentium Implantium (K041368) Manufactured by Dentium Co., Ltd OCT 3 1 2013 3.2 Implantium Prosthetics(K052957) Manufactured by Dentiumn Co., Ltd 4. Device Description: The Luna Dental Implant System is a device of pure titanium(A… | 2006 |
What descends from it? (6)
4 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 19 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K172345 (Warantec Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K041368.
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 Luna Dental 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/K123155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123155: Luna 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/K123155
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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