510(k) · Cleared
ClearedTruAbutment DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truabutment · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 20, 2016 as substantially equivalent to K123627 (Hiossen, Inc., 2013) after a 254-day review. Its family tree reaches back 12 generations to 1990. 18 later devices descend from it.
- Decided
- May 20, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 29 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 2 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 1 generation backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- This deviceK152559 TruAbutment DSTruabutment · 2016
- Descendant · cites it directly · 17 of its ownK170259 TruAbutment DSTruabutment · 2017
- Descendant · 2 generations on · 8 of its ownK172304 TruAbutment DSTruabutment, Inc. · 2018
- Descendant · 3 generations on · 7 of its ownK183106 TruAbutment DSTruabutment, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- Descendant · 4 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 2 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 1 generation backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- This deviceK152559 TruAbutment DSTruabutment · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K170259TruAbutment DSTruabutment · 2017 · cites it directly17descendants
- K172304TruAbutment DSTruabutment, Inc. · 2018 · 2 generations on8descendants
- K183106TruAbutment DSTruabutment, Inc. · 2020 · 3 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · 2 generations on6descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −2 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −1 | K123627 | ET Smartfit Abutment | Hiossen, Inc. | 2013 | — |
| 0 (this device) | K152559 | TruAbutment DS | Truabutment | 2016 | — |
| +1 | K170259 | TruAbutment DS | Truabutment | 2017 | — |
| +2 | K172304 | TruAbutment DS | Truabutment, Inc. | 2018 | — |
| +3 | K183106 | TruAbutment DS | Truabutment, Inc. | 2020 | — |
| +2 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| +4 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 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? (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 |
|---|---|---|---|
| * | K123627 | ET Smartfit AbutmentSummary page 6…stantial equivalency of the device. Predicate Devices: The subject device is substantially equivalent to the following predicate device: ET SmartFit Abutment K123627 Comparison between Predicate and Proposed Device Attributes Proposed Device Predicate… | 2013 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170259 | TruAbutment DS | 2017 | 17 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K170259 (Truabutment, 2017) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K123627.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.
All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152559: TruAbutment DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152559
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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