510(k) · Cleared
ClearedSimpleline II Abutment System
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 Jan 26, 2012 as substantially equivalent to K070228 (Dentium Co., Ltd., 2007) and 2 other predicates after a 192-day review. Its family tree reaches back 3 generations to 1994. 60 later devices descend from it.
- Decided
- Jan 26, 2012
- Review
- 192 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931767 (1994). 4 ancestors in all. 60 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 2 generations backK052957 Implantium ProstheticsDentium Co., Ltd. · 2006
- 1 generation backK070228 Implantium ProstheticsDentium Co., Ltd. · 2007
- This deviceK112045 Simpleline II Abutment SystemDentium Co., Ltd. · 2012
- Descendant · cites it directly · 54 of its ownK121843 NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · 2 generations on · 32 of its ownK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- Descendant · 3 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 3 generations on · 10 of its ownK153521 IH Implant SystemSewonmedix, Inc. · 2016
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd. · 2012 · cites it directly54descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 2 generations on44descendants
- K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · 2 generations on32descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 3 generations on30descendants
- K153521IH Implant SystemSewonmedix, Inc. · 2016 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −2 | K052957 | Implantium Prosthetics | Dentium Co., Ltd. | 2006 | — |
| −1 | K070228 | Implantium Prosthetics | Dentium Co., Ltd. | 2007 | — |
| 0 (this device) | K112045 | Simpleline II Abutment System | Dentium Co., Ltd. | 2012 | — |
| +1 | K121843 | NP-Cast Abutment System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +2 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| +3 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +3 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
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 |
|---|---|---|
| 2012 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K070228 | Implantium ProstheticsSummary page 1…ation name: Abutment, Dental, Endosseous implant NI-A, 21CFR872.3630 3. Predicated Device Implantium Prosthetics, Dentium Co., Ltd. (K070228, K052957) Implantium, Dentiumn Co., Ltd. (K04 1368) 4. Device Description SimpleLine II Abutment system is intended for u… | 2007 |
| * | K052957 | Implantium ProstheticsSummary page 1…e: Abutment, Dental, Endosseous implant NI-A, 21CFR872.3630 3. Predicated Device Implantium Prosthetics, Dentium Co., Ltd. (K070228, K052957) Implantium, Dentiumn Co., Ltd. (K04 1368) 4. Device Description SimpleLine II Abutment system is intended for use as an… | 2006 |
| * | K041368 | Dentium CO., LTD. ImplantiumSummary page 1…nt NI-A, 21CFR872.3630 3. Predicated Device Implantium Prosthetics, Dentium Co., Ltd. (K070228, K052957) Implantium, Dentiumn Co., Ltd. (K04 1368) 4. Device Description SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation. It… | 2004 |
What descends from it? (60)
See all 605 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 18 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K121843 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 54 descendants of its own.
- 1 other device also cites its predicate K070228.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112045: Simpleline II Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112045
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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