510(k) · Cleared
ClearedDESS Dental Smart Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terrats Medical SL · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 15, 2018 as substantially equivalent to K170588 (Terrats Medical SL, 2017) and 13 other predicates after a 175-day review. Its family tree reaches back 16 generations to 1996. 51 later devices descend from it.
- Decided
- Jun 15, 2018
- Review
- 175 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 16 generations to K960026 (1996). 317 ancestors in all, the oldest K781060 (1978). 51 later devices descend from it, 7 citing it directly.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · cites it directly · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · cites it directly · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- Descendant · cites it directly · 19 of its ownK212577 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- Descendant · 2 generations on · 15 of its ownK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- Descendant · cites it directly · 14 of its ownK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 6 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 5 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 4 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
2019high 11 (2024) · low 1 (2019)2026
Most influential descendants
Showing 5 of 51 · See all- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · cites it directly38descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · cites it directly20descendants
- K212577DESS Dental Smart SolutionsTerrats Medical SL · 2021 · cites it directly19descendants
- K203464DESS Dental Smart SolutionsTerrats Medical SL · 2021 · 2 generations on15descendants
- K222288DESS Dental Smart SolutionsTerrats Medical SL · 2022 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −6 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −5 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −3 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| 0 (this device) | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +1 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +1 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| +1 | K212577 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| +2 | K203464 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| +1 | K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 23 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (14)
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 |
|---|---|---|---|
| * | K170588 | DESS Dental Smart SolutionsSummary page 4…e NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Device K092341 Low Profile Abutment B… | 2017 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 5…K173908 Page 2 of 7 Compatible Implant Systems K063341 3i OSSEOTITE Certain® Dental Implants Implant Innovations, Inc. K063286 OSSEOTITE® Dental Imp… | 2007 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 5…Compatible Implant Systems K063341 3i OSSEOTITE Certain® Dental Implants Implant Innovations, Inc. K063286 OSSEOTITE® Dental Implants Implant Innovations, Inc. K101732 OsseoSpeedTM… | 2007 |
| * | K101732 | Astra Tech Implant SystemSummary page 5…® Dental Implants Implant Innovations, Inc. K063286 OSSEOTITE® Dental Implants Implant Innovations, Inc. K101732 OsseoSpeedTM Astra Tech AB K073075 FRIADENT Implant Systems… | 2011 |
| * | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsSummary page 5…E® Dental Implants Implant Innovations, Inc. K101732 OsseoSpeedTM Astra Tech AB K073075 FRIADENT Implant Systems DENTSPLY International, Inc. K142260 NobelActive®… | 2008 |
| * | K142260 | NobelActiveSummary page 5…M Astra Tech AB K073075 FRIADENT Implant Systems DENTSPLY International, Inc. K142260 NobelActive® Nobel Biocare AB K073142 NobelReplace Hexagonal Implant… | 2015 |
| * | K073142 | Nobelreplace Hexagonal ImplantSummary page 5…nt Systems DENTSPLY International, Inc. K142260 NobelActive® Nobel Biocare AB K073142 NobelReplace Hexagonal Implants Nobel Biocare AB K050705 TiUnite® Implants… | 2008 |
| * | K050705 | Tiunite ImplantsSummary page 5…belActive® Nobel Biocare AB K073142 NobelReplace Hexagonal Implants Nobel Biocare AB K050705 TiUnite® Implants Nobel Biocare AB K050406 NOBELSPEEDY™ Implants… | 2005 |
| * | K050406 | Nobelspeedy ImplantsSummary page 5…belReplace Hexagonal Implants Nobel Biocare AB K050705 TiUnite® Implants Nobel Biocare AB K050406 NOBELSPEEDY™ Implants Nobel Biocare USA LLC Various Brånemark System… | 2005 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 5…B K050406 NOBELSPEEDY™ Implants Nobel Biocare USA LLC Various Brånemark System Implants – K022562 Nobel Biocare AB Immediate Function Indication… | 2002 |
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 5…m Implants – K022562 Nobel Biocare AB Immediate Function Indication K140878 Straumann® Bone Level Tapered Implants Straumann USA, LLC K062129 P.004 Implants… | 2014 |
| * | K062129 | P.0004 ImplantsSummary page 5…Biocare AB Immediate Function Indication K140878 Straumann® Bone Level Tapered Implants Straumann USA, LLC K062129 P.004 Implants Institut Straumann AG Straumann® Dental Implant… | 2006 |
| * | K130222 | Straumann Dental Implant SystemSummary page 5…K062129 P.004 Implants Institut Straumann AG Straumann® Dental Implant System SLActive and K130222 Straumann USA, LLC Roxolid Product Families… | 2013 |
| * | K112160 | Tapered Screw-Vent X ImplantSummary page 5…em SLActive and K130222 Straumann USA, LLC Roxolid Product Families K112160 Tapered Screw-Vent® X Implant Zimmer Dental, Incorporated INDICATIONS FOR USE DESS Dental Smart Sol… | 2011 |
| † | K092341 | Low Profile Abutments - Internal and External Connection | 2009 |
| † | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | 2015 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K160784 | CAM Titanium Blanks | 2016 |
What descends from it? (51)
See all 517 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191986 | DESS Dental Smart Solutions | 2019 | 38 |
| K212628 | DESS Dental Smart Solutions | 2022 | 20 |
| K212577 | DESS Dental Smart Solutions | 2021 | 19 |
| K222288 | DESS Dental Smart Solutions | 2022 | 14 |
| K191919 | Elos Accurate Hybrid Base | 2020 | 11 |
| K222269 | DESS Dental Smart Solutions | 2022 | 3 |
| K243212 | DESS Dental Smart Solutions | 2025 | 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 22 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 43 of the 317 ancestors have a recall of any class.
- Of its descendants, K191986 (Terrats Medical SL, 2019) has gone furthest, with 38 descendants of its own.
- 15 other devices also cite its predicate K170588.
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
2007high 51 (2023) · low 19 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
2007high 211 (2021) · low 90 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
2007high 36 (2016) · low 0 (2009)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
2007high 858 (2015) · low 1 (2007)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?
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical 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/K173908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173908: DESS Dental Smart Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173908
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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