510(k) · Cleared
ClearedImplantium Prosthetics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 27, 2006 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) and 1 other predicate after a 279-day review. Its family tree reaches back 1 generation to 1994. 78 later devices descend from it.
- Decided
- Jul 27, 2006
- Review
- 279 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931767 (1994). 2 ancestors in all. 78 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- This deviceK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 32 of its ownK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K070228Implantium ProstheticsDentium Co., Ltd. · 2007 · cites it directly63descendants
- 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
- K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| 0 (this device) | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| +1 | 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 | — |
| +3 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 19 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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…tium Prosthetics Common Name -Abutment Classification Name - Endosseous dental implant abutment 3. Predicate Device: Implantium, Dentium Co., Ltd. K04 1368 Astra Tech Implants, Astra Tech Inc., K93 1767 4. Classifications Names & Citations: 21 CFR 872.3630, NHA, Endo… | 2004 |
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 1…lassification Name - Endosseous dental implant abutment 3. Predicate Device: Implantium, Dentium Co., Ltd. K04 1368 Astra Tech Implants, Astra Tech Inc., K93 1767 4. Classifications Names & Citations: 21 CFR 872.3630, NHA, Endosseous dental implant abutment, Class El 5. Descripti… | 1994 |
What descends from it? (78)
See all 7810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070228 | Implantium Prosthetics | 2007 | 63 |
| K112045 | Simpleline II Abutment System | 2012 | 60 |
| K081748 | Oneplant Dental Implant System | 2009 | 9 |
| K141457 | Dentium Implantium and Superline Abutments | 2014 | 6 |
| K123155 | Luna Dental Implant System | 2013 | 6 |
| K192436 | Healing Abutments and Cover Screws | 2020 | 5 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech… | 2024 | 0 |
| K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 | 0 |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | 2015 | 0 |
| K111189 | Syntec Dental Implant | 2012 | 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 NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052957: Implantium Prosthetics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052957
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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