510(k) · Cleared
ClearedTruAbutment DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truabutment, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 19, 2020 as substantially equivalent to K170259 (Truabutment, 2017) after a 338-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Jun 19, 2020
- Review
- 338 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- 2 generations backK152559 TruAbutment DSTruabutment · 2016
- 1 generation backK170259 TruAbutment DSTruabutment · 2017
- This deviceK191913 TruAbutment DSTruabutment, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 4 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 3 generations backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- 2 generations backK152559 TruAbutment DSTruabutment · 2016
- 1 generation backK170259 TruAbutment DSTruabutment · 2017
- This deviceK191913 TruAbutment DSTruabutment, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −4 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −3 | K123627 | ET Smartfit Abutment | Hiossen, Inc. | 2013 | — |
| −2 | K152559 | TruAbutment DS | Truabutment | 2016 | — |
| −1 | K170259 | TruAbutment DS | Truabutment | 2017 | — |
| 0 (this device) | K191913 | TruAbutment DS | 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 |
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 |
|---|---|---|---|
| * | K170259 | TruAbutment DSSummary page 5…19/2020 Predicate Devices/Reference Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate • TruAbutment DS (K170259) Reference Device • TruAbutment DS (K152559) • Zimmer® Patient Specific Abutment (K143505) • Biomet 3i Certain… | 2017 |
| † | K152559 | TruAbutment DS | 2016 |
| † | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | 2015 |
| † | K130949 | CP4 Osseotite Certain Dental Implants | 2013 |
| † | K161987 | UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure | 2017 |
| † | K170608 | UF (II) Implant System | 2018 |
| † | K173975 | UF (II) Wide Fixture | 2018 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K083561 | Neoss Proactive Implant | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 2 other devices also cite its predicate K170259.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: • Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm • DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0…
Read the full statement (612 words)
The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
• Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
• DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
• Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm
The available range of diameters is summarized below:
Biomet 3i Certain® (K130949)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex
DIO UF(II) Internal Submerged (K161987, K170608, K173975)
Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex
Megagen AnyRidge® (K140091)
Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex
Neoss ProActive® (K083561)
Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex
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/K191913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191913: 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/K191913
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