510(k) · Cleared
ClearedDentium Implantium and Superline Abutments
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 12, 2014 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) and 3 other predicates after a 163-day review. Its family tree reaches back 8 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 12, 2014
- Review
- 163 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K944964 (1995). 45 ancestors in all, the oldest K871863 (1987). 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 2 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 1 generation backK052823 Implantium AbutmentsDentium, Inc. · 2006
- This deviceK141457 Dentium Implantium and Superline AbutmentsDentium Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243731 HEXIM Implant; Samwon General AbutmentsP&A USA · 2025
- Descendant · 2 generations on · 0 of its ownK221847 Ni2 Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231429 S-Plant Dental Implant SystemIdis Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · cites it directly2descendants
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · cites it directly0descendants
- K243731HEXIM Implant; Samwon General AbutmentsP&A USA · 2025 · 2 generations on0descendants
- K221847Ni2 Implant SystemNewton Implant Systems, Inc. · 2024 · 2 generations on0descendants
- K231429S-Plant Dental Implant SystemIdis Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −2 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K052823 | Implantium Abutments | Dentium, Inc. | 2006 | — |
| 0 (this device) | K141457 | Dentium Implantium and Superline Abutments | Dentium Co., Ltd. | 2014 | — |
| +1 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +1 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +2 | K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025 | — |
| +2 | K221847 | Ni2 Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +1 | K231429 | S-Plant Dental Implant System | Idis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (4)
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 4…Classification name: Abutment, Implant, Dental, Endosseous NHA, 21 CFR 872.3630 3. Predicated Device k041368 - Dentium Co. Ltd., Implantium k052823 - Implantium Abutments k052957 - Implantium Prosthetics… | 2004 |
| * | K052823 | Implantium AbutmentsSummary page 4…ndosseous NHA, 21 CFR 872.3630 3. Predicated Device k041368 - Dentium Co. Ltd., Implantium k052823 - Implantium Abutments k052957 - Implantium Prosthetics k112045 - SimpleLine II Abutment System… | 2006 |
| * | K052957 | Implantium ProstheticsSummary page 4…NHA, 21 CFR 872.3630 3. Predicated Device k041368 - Dentium Co. Ltd., Implantium k052823 - Implantium Abutments k052957 - Implantium Prosthetics k112045 - SimpleLine II Abutment System 4. Description Dentium Impla… | 2006 |
| * | K112045 | Simpleline II Abutment SystemSummary page 4…icated Device k041368 - Dentium Co. Ltd., Implantium k052823 - Implantium Abutments k052957 - Implantium Prosthetics k112045 - SimpleLine II Abutment System 4. Description Dentium Implantium and SuperLine Abutments are intended for… | 2012 |
What descends from it? (6)
4 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 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K221866 (Newton Implant Systems, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K041368.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Dentium Prosthetics are intended for use as an aid in prosthetic
rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141457: Dentium Implantium and Superline Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141457
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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