510(k) · Cleared
ClearedTruAbutment DS, TruBase
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 Jul 14, 2022 as substantially equivalent to K203649 (Truabutment, Inc., 2021) after a 206-day review. Its family tree reaches back 20 generations to 1990. 1 later device descends from it.
- Decided
- Jul 14, 2022
- Review
- 206 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K894844 (1990). 211 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 16 generations between
- 3 generations backK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- 2 generations backK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- 1 generation backK203649 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- This deviceK213961 TruAbutment DS, TruBaseTruabutment, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
Show all 20 generations
- Root · 20 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 19 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 18 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 17 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 16 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 15 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 14 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 13 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 12 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 11 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 10 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 9 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 8 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 7 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 6 generations backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- 5 generations backK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- 4 generations backK171532 TruBase STruabutment, Inc. · 2018
- 3 generations backK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- 2 generations backK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- 1 generation backK203649 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- This deviceK213961 TruAbutment DS, TruBaseTruabutment, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −19 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −18 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −17 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −16 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −15 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −14 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −13 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −12 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −11 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −10 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −9 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −8 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −7 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| −6 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| −5 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| −4 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| −3 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| −2 | K202579 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| −1 | K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| 0 (this device) | K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | 2022 | — |
| +1 | K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 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 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 15 | 0 |
| 2007 | 15 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K203649 | TruAbutment DS, TruBaseSummary page 5…2 Predicate Devices/ Reference Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate: • TruAbutment DS (K203649) by TruAbutment Inc. Reference Devices for OEM Compatibilities: • Osstem TS Fixture System(K121995) by Osstem Implant… | 2021 |
| † | K121995 | TS Fixture System | 2012 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 |
| † | K143022 | BioHorizons Tapered Internal Implants | 2015 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 |
| † | K202942 | Straumann 4 mm Short Implants | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231210 | DGA Abutment | 2024 | 0 |
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 32 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 211 ancestors have a recall of any class.
- Of its descendants, K231210 (Modern Dental Laboratory (Dg) Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203649.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
TruAbutment DS 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: • Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling…
Read the full statement (197 words)
TruAbutment DS
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:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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.
TruBase
TruBase 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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
• Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
• BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0, 3.4, 3.8, 4.6, 5.8 mm
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213961: TruAbutment DS, TruBase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213961
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