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 Sep 15, 2021 as substantially equivalent to K202579 (Truabutment, Inc., 2021) after a 275-day review. Its family tree reaches back 19 generations to 1990. 3 later devices descend from it.
- Decided
- Sep 15, 2021
- Review
- 275 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K894844 (1990). 210 ancestors in all, the oldest K871863 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 15 generations between
- 3 generations backK171532 TruBase STruabutment, Inc. · 2018
- 2 generations backK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- 1 generation backK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- This deviceK203649 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213961 TruAbutment DS, TruBaseTruabutment, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK241485 TruAbutment DS; TruBaseTruabutment, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
Show all 19 generations
- Root · 19 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 18 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 17 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 16 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 15 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 14 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 13 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 12 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 11 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 10 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 9 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 8 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 7 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 6 generations backK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- 5 generations backK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- 4 generations backK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- 3 generations backK171532 TruBase STruabutment, Inc. · 2018
- 2 generations backK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- 1 generation backK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
- This deviceK203649 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −18 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −17 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −16 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −15 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −14 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −13 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −12 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −11 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −10 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −9 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −8 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −7 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −6 | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| −5 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| −4 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| −3 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| −2 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| −1 | K202579 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| 0 (this device) | K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
| +1 | K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | 2022 | — |
| +1 | K241485 | TruAbutment DS; TruBase | Truabutment, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K202579 | TruAbutment DS, TruBase Cleared while this submission was under review Summary page 5…72.3630 • Device Class: Class II • Date prepared: 09/14/2021 Primary Predicate / Reference Devices: Primary Predicate: • TruAbutment DS, TruBase (K202579) by TruAbutment Inc. Reference Devices: • MIS C1 Narrow Platform Conical Connection Implant System (K172505) by MIS Im… | 2021 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K050258 | Groovy Implants | 2005 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
| † | K191256 | Straumann BLX Ø3.5 mm Implants | 2019 |
| † | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | 2011 |
| † | K152559 | TruAbutment DS | 2016 |
| † | K200817 | URIS OMNI Narrow System & Prosthetic | 2020 |
What descends from it? (3)
2 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 31 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 210 ancestors have a recall of any class.
- Of its descendants, K213961 (Truabutment, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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: • MIS Cl Conical Connection Implant (Kl 72505, Kl 12162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) • Neodent Implant System - GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) • Nobel Biocare Groovy Implants…
Read the full statement (279 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:
• MIS Cl Conical Connection Implant (Kl 72505, Kl 12162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• Neodent Implant System - GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• Straumann BLX Implant (Kl 73961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• Straumann Tissue Level Implant (Kl 11357)
: 3.3(NNC)
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 screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:
• MIS Cl Conical Connection Implant (Kl72505, Kl12162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• Neodent Implant System - GM Helix (K163194, Kl80536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• Straumann BLX Implant (Kl73961, Kl81703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• Straumann Tissue Level Implant (Kl11357)
: 3.3(NNC)
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/K203649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203649: 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/K203649
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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