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 Nov 20, 2007 as substantially equivalent to K052957 (Dentium Co., Ltd., 2006) after a 300-day review. Its family tree reaches back 2 generations to 1994. 63 later devices descend from it.
- Decided
- Nov 20, 2007
- Review
- 300 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931767 (1994). 3 ancestors in all. 63 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 1 generation backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- This deviceK070228 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
- Descendant · 4 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- 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
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 4 generations on30descendants
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) | 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 | — |
| +4 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 13 | 0 |
| 2024 | 9 | 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? (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 |
|---|---|---|---|
| * | K052957 | Implantium ProstheticsSummary page 1…ic Common Name - Dental Implant Classification Name - Endosseous dental implant abutment 3. Predicate Device: Implantium Prosthetic, Dentium Co., Ltd., K052957 4. Classifications Names & Citations: 21CFR 872.3630, NHA, Endosseous dental implant abutment, Class II 5. Description… | 2006 |
What descends from it? (63)
See all 632 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 13 years and passes through 2 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, K112045 (Dentium Co., Ltd., 2012) has gone furthest, with 60 descendants of its own.
- 9 other devices also cite its predicate K052957.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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/K070228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070228: 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/K070228
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