510(k) · Cleared
ClearedImplantium Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 21, 2006 as substantially equivalent to K041368 (Dentium Co., Ltd., 2004) and 1 other predicate after a 140-day review. Its family tree reaches back 7 generations to 1995. 21 later devices descend from it.
- Decided
- Feb 21, 2006
- Review
- 140 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K944964 (1995). 40 ancestors in all, the oldest K871863 (1987). 21 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 1 generation backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- This deviceK052823 Implantium AbutmentsDentium, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK081748 Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009
- Descendant · 2 generations on · 7 of its ownK172100 URIS OMNI SystemTruabutment, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK141457 Dentium Implantium and Superline AbutmentsDentium Co., Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K081748Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009 · cites it directly9descendants
- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · 2 generations on7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
- K141457Dentium Implantium and Superline AbutmentsDentium Co., Ltd. · 2014 · cites it directly6descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −1 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K052823 | Implantium Abutments | Dentium, Inc. | 2006 | — |
| +1 | K081748 | Oneplant Dental Implant System | Warantec Co., Ltd. | 2009 | — |
| +2 | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +1 | K141457 | Dentium Implantium and Superline Abutments | Dentium Co., Ltd. | 2014 | — |
| +2 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
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 | 7 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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…Endosseous dental implant abutments Classification: Class II Product Code: NHA Regulation number: 21 CFR872.3630 Predicate devices: Implantium, K041368 Nobel Biocare Br.nemark; K042658 Device description: The Implantium abutments are devices made of pure… | 2004 |
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…Class II Product Code: NHA Regulation number: 21 CFR872.3630 Predicate devices: Implantium, K041368 Nobel Biocare Br.nemark; K042658 Device description: The Implantium abutments are devices made of pure titanium, titanium alloys, and pl… | 2004 |
What descends from it? (21)
See all 215 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 11 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K081748 (Warantec Co., Ltd., 2009) has gone furthest, with 9 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.
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 Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052823: Implantium Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052823
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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