510(k) · Cleared
ClearedMagDen 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 Jul 26, 2017 as substantially equivalent to K031106 (Imtec Corp., 2003) after a 286-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Jul 26, 2017
- Review
- 286 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031106 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003 · Recalled
- This deviceK162867 MagDen Dental Implant SystemShinhung Mst Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK192614 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22… | Imtec Corp. | 2003 | 1 |
| 0 (this device) | K162867 | MagDen Dental Implant System | Shinhung Mst Co., Ltd. | 2017 | — |
| +1 | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Megagen Implant Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 4…lant (CFR 872.3640) Product Codes : DZE (Primary), NHA 4. Predicate Device 4.1. Primary Predicate Device: IMTEC Sendax MDI and MDI Plus (K031106) by IMTEC Corporation 4.2. Reference Predicate Device: IMTEC MDI MII One-Piece Implant, 2.9mm (K081653) by IMTEC Co… | 2003 |
| † | K081653 | Mdi Mii One-Piece Implant, 2.9MM | 2008 |
| † | K052957 | Implantium Prosthetics | 2006 |
| † | K142557 | Anker Dental Implant System - SB-III, ST and AT series | 2015 |
| † | K984297 | Magna Abutment | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | 2020 | 0 |
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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MagDen 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. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162867: MagDen 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/K162867
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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