510(k) · Cleared
ClearedTruBase S
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 Sep 11, 2018 as substantially equivalent to K151324 (Straumann USA, LLC, 2015) after a 474-day review. Its family tree reaches back 16 generations to 1990. 7 later devices descend from it.
- Decided
- Sep 11, 2018
- Review
- 474 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K894844 (1990). 189 ancestors in all, the oldest K871863 (1987). 7 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 12 generations between
- 3 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 2 generations backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- 1 generation backK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- This deviceK171532 TruBase STruabutment, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK203649 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK213961 TruAbutment DS, TruBaseTruabutment, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK241485 TruAbutment DS; TruBaseTruabutment, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 15 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 14 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 13 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 12 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 11 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 10 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 9 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 8 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 7 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 6 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 5 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 4 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 3 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 2 generations backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- 1 generation backK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- This deviceK171532 TruBase STruabutment, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · cites it directly6descendants
- K202579TruAbutment DS, TruBaseTruabutment, Inc. · 2021 · 2 generations on4descendants
- K203649TruAbutment DS, TruBaseTruabutment, Inc. · 2021 · 3 generations on3descendants
- K213961TruAbutment DS, TruBaseTruabutment, Inc. · 2022 · 4 generations on1descendant
- K241485TruAbutment DS; TruBaseTruabutment, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −15 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −14 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −13 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −12 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −11 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −10 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −9 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −8 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −7 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −6 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −5 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −4 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −3 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| −2 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| −1 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| 0 (this device) | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| +1 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| +2 | K202579 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| +3 | K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| +4 | K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | 2022 | — |
| +4 | K241485 | TruAbutment DS; TruBase | Truabutment, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 13 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K151324 | Straumann Variobase for CERECSummary page 4…ate Devices The subject device is substantially equivalent to the following predicate device: • Primary Predicate o Straumann® Variobase® for CEREC® (K151324) • Reference Predicate o Neodent Implant System Titanium Base for CEREC® (K160964) o Link Abutment… | 2015 |
| † | K160964 | Neodent Implant System - Titanium Base for CEREC | 2016 |
| † | K160519 | Link Abutment for CEREC | 2016 |
| † | K152559 | TruAbutment DS | 2016 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201197 | TruAbutment DS, TruBase S | 2021 | 6 |
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 28 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 189 ancestors have a recall of any class.
- Of its descendants, K201197 (Truabutment, Inc., 2021) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K151324.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for
patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or
cement-retained single tooth and bridge restorations. It is compatible with the following systems:
o Zimmer TSV - 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software
or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.
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/K171532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171532: TruBase S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171532
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