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 Oct 23, 2025 as substantially equivalent to K242340 (Terrats Medical SL, 2024) after an 84-day review. Its family tree reaches back 21 generations to 1996.
- Decided
- Oct 23, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K960026 (1996). 328 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations between
- 3 generations backK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- 2 generations backK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- 1 generation backK242340 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK252384 DESS® Dental Smart SolutionsTerrats Medical SL · 2025
Show all 21 generations
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 20 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 19 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 18 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 17 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 14 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 13 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 12 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 11 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 10 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 9 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 8 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 7 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 6 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 5 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 4 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 3 generations backK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- 2 generations backK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- 1 generation backK242340 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK252384 DESS® Dental Smart SolutionsTerrats Medical SL · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −20 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −19 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −17 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −14 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −13 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −12 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −11 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −10 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −9 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −8 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −7 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −6 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −5 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −4 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −3 | K203464 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| −2 | K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| −1 | K242340 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| 0 (this device) | K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | 2025 | — |
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 | 24 | 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 |
| 2017 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K242340 | DESS Dental Smart SolutionsSummary page 6…espiratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE AND REFERENCE DEVICE INFORMATION Primary Predicate Device K242340, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K240208, DESS Dental Smart Solutions, Terrats Medical SL K2222… | 2024 |
| † | K240208 | DESS Dental Smart Solutions | 2024 |
| † | K222288 | DESS Dental Smart Solutions | 2022 |
| † | K230143 | DESS Dental Smart Solutions | 2023 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K212538 | DESS Dental Implants | 2021 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
| † | K111287 | Astra Tech Implant System | 2011 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K042429 | The Prodigy System Dental Implants | 2004 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K201225 | Neodent Implant System - GM Helix Implants 7.0 | 2020 |
| † | K142260 | NobelActive | 2015 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | 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 |
| † | K210855 | Straumann BLX Implant System | 2021 |
| † | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 2022 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 |
| † | K061319 | Spectra System | 2006 |
| † | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2… | 2020 |
| † | K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 |
| † | K201553 | Simply Iconic Implants | 2021 |
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 44 of the 328 ancestors have a recall of any class.
- 1 other device also cites its predicate K242340.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
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 DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems for Pre-Milled Abutments Compatible Implant System (Connection) | Implant…
Read the full statement (429 words)
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 DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
Compatible Implant Systems for Pre-Milled Abutments
Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm
Astra Tech EV (Internal Taper) | 3.0, 3.6, 4.2 | 3.0, 3.6, 4.2
BioHorizons Internal (Internal Hex) | 3.0, 3.4, 3.8; 3.8, 4.2, 4.6; 4.6, 5.2, 5.8 | 3.0; 3.5; 4.5
Simply Iconic™ (Internal Conical) | 3.2, 3.7, 4.2, 4.7; 4.7, 5.2, 5.7 | 3.0; 3.4
InterActive (Internal Conical) | 3.2, 3.7; 4.3, 5.0 | 3.0; 3.4
Legacy™1 (Internal Hex) | 3.7, 4.2; 4.7 | 3.5; 4.5
Legacy™2, simplyLegacy™2, Legacy™3, simplyLegacy™3, Legacy™4 (Internal Hex) | 3.2; 3.7, 4.2; 4.7, 5.2 | 3.0; 3.5; 4.5
Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM
Nobel Biocare NobelActive® (Conical Connection) | 3.0; 3.5; 4.3, 5.0 | 3.0; NP (3.5); RP (3.9)
NobelReplace Conical Connection (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9)
NobelParallel Conical Connection (Conical Connection) | 3.75; 4.3, 5.0 | NP (3.5); RP (3.9)
Osstem® TS | 3.5 | Mini
Hiossen® ET (Internal Taper) | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular
Straumann Bone Level (CrossFit® Morse Taper) | 3.3; 4.1, 4.8 | NC; RC
Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5; 5.0, 5.5, 6.5 | RB; WB
Zimmer Screw-Vent® Tapered Screw-Vent® (Internal Hex) | 3.3, 3.7, 4.1; 4.7 | 3.5; 4.5
Compatible Implant Systems for Multi-Unit Abutments
Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm
Biomet 3i OSSEOTITE® (External Hex) | 3.25; 3.75, 4.0 | 3.4; 4.1
InterActive (Internal Conical) | 3.2, 3.7; 4.3, 5.0 | 3.0; 3.4
Simply Iconic™ (Internal Conical) | 3.2, 3.7, 4.2, 4.7; 4.7, 5.2, 5.7 | 3.0; 3.4
Legacy™1 (Internal Hex) | 3.7, 4.2; 4.7 | 3.5; 4.5
Legacy™2, simplyLegacy™2, Legacy™3, simplyLegacy™3, Legacy™4 (Internal Hex) | 3.2; 3.7, 4.2; 4.7, 5.2 | 3.0; 3.5; 4.5
Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM
Nobel Biocare NobelActive® (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9)
NobelReplace Conical Connection (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9)
NobelParallel Conical Connection (Conical Connection) | 3.75; 4.3, 5.0 | NP (3.5); RP (3.9)
Straumann Bone Level (CrossFit® Morse Taper) | 3.3; 4.1, 4.8 | NC; RC
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252384: DESS® Dental Smart Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252384
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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