510(k) · Cleared
Recalled · 2007Dentium CO., LTD. Implantium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 29, 2004 after a 66-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 98 later devices descend from it. It has been recalled once.
- Decided
- Jul 29, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 1
98 later devices descend from it, 10 citing it directly.
- This deviceK041368 Dentium CO., LTD. ImplantiumDentium Co., Ltd. · 2004
- Descendant · cites it directly · 78 of its ownK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- Descendant · 2 generations on · 63 of its ownK070228 Implantium ProstheticsDentium Co., Ltd. · 2007
- Descendant · cites it directly · 60 of its ownK112045 Simpleline II Abutment SystemDentium Co., Ltd. · 2012
- Descendant · 2 generations on · 54 of its ownK121843 NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 3 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K052957Implantium ProstheticsDentium Co., Ltd. · 2006 · cites it directly78descendants
- K070228Implantium ProstheticsDentium Co., Ltd. · 2007 · 2 generations on63descendants
- K112045Simpleline II Abutment SystemDentium Co., Ltd. · 2012 · cites it directly60descendants
- K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012 · 2 generations on54descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041368 | Dentium CO., LTD. Implantium | Dentium Co., Ltd. | 2004 | — |
| +1 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| +2 | K070228 | Implantium Prosthetics | Dentium Co., Ltd. | 2007 | — |
| +1 | K112045 | Simpleline II Abutment System | Dentium Co., Ltd. | 2012 | — |
| +2 | K121843 | NP-Cast Abutment System | Osstem Implant Co., Ltd. | 2012 | — |
| +3 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 9 | 0 |
| 2019 | 1 | 0 |
| 2020 | 10 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 21 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012965 | Astra Tech Implants-Dental System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Legally Marketed Device To Which Claim Substantial Equivalence: Astra Tech Implants-Dental System K012965 II. INDICATIONS FOR USE The Dentium Co., Ltd Implantium is intended to be surgically placed in the bone of… |
What descends from it? (98)
See all 9810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052957 | Implantium Prosthetics | 2006 | 78 |
| K112045 | Simpleline II Abutment System | 2012 | 60 |
| K060501 | Implantium II | 2006 | 26 |
| K052823 | Implantium Abutments | 2006 | 21 |
| K081748 | Oneplant Dental Implant System | 2009 | 9 |
| K141457 | Dentium Implantium and Superline Abutments | 2014 | 6 |
| K123155 | Luna Dental Implant System | 2013 | 6 |
| K131165 | Anker Dental Implant System | 2013 | 1 |
| K110425 | HC-Bios Dental Implant | 2012 | 1 |
| K111189 | Syntec Dental Implant | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2007 | Not classified | Z-1119-2007 | Other | Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052957 (Dentium Co., Ltd., 2006) has gone furthest, with 78 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Dentium Co., Ltd Implantium 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.
This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, IIor III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041368: Dentium CO., LTD. Implantium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041368
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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