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 May 22, 2025 as substantially equivalent to K221301 (Terrats Medical SL, 2023) and 1 other predicate after an 80-day review. Its family tree reaches back 21 generations to 1996.
- Decided
- May 22, 2025
- Review
- 80 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K960026 (1996). 327 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 backK221301 DESS Dental Smart SolutionsTerrats Medical SL · 2023
- This deviceK250639 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 backK221301 DESS Dental Smart SolutionsTerrats Medical SL · 2023
- This deviceK250639 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 | K221301 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 | — |
| 0 (this device) | K250639 | 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 | 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? (2)
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 |
|---|---|---|---|
| * | K221301 | DESS Dental Smart SolutionsSummary page 6…ode PNP Classification Panel Dental Products Panel Reviewing Division DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K221301, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Device K240982, DESS Dental Smart Solutions, Terrats Med… | 2023 |
| * | K240982 | DESS Dental Smart SolutionsSummary page 6…ision of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K221301, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Device K240982, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K171876, Amann Ceramill Zolid Gen-X and Zolid Bion K190079… | 2024 |
| † | K171876 | Ceramill Zolid HT+ white | 2017 |
| † | K190079 | ArgenZ HT+ | 2019 |
| † | K071410 | Argen Pearl Brand Zirconia | 2007 |
| † | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2014 |
| † | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | 2015 |
| † | K110719 | Origin Zirconia | 2011 |
| † | K180703 | VITA YZ ST and VITA YZ XT | 2018 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K193352 | AbutmentCAD | 2021 |
| † | K140347 | Ankylos C/X Implant System | 2014 |
| † | K111287 | Astra Tech Implant System | 2011 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K042429 | The Prodigy System Dental Implants | 2004 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
| † | K083496 | Camlog Implant System Modified Implants and Abutments | 2009 |
| † | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K142260 | NobelActive | 2015 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K050705 | Tiunite Implants | 2005 |
| † | K050406 | Nobelspeedy Implants | 2005 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
| † | K161604 | OSSTEM Implant System | 2016 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K011028 | Screw-Vent Dental Implant System | 2001 |
| † | K112160 | Tapered Screw-Vent X Implant | 2011 |
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 10 months on median.
- 44 of the 327 ancestors have a recall of any class.
- 2 other devices also cite its predicate K221301.
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 Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry…
Read the full statement (368 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 Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.
Compatible Implant Systems
Implant System Compatibility — Implant Diameter (mm) — Implant Platform Name
Ankylos C/X — 3.5, 4.5, 5.5 — 3.5, 4.5, 5.5
3.0 — 3.0
3.6 — 3.6
Astra Tech EV — 4.2 — 4.2
4.8 — 4.8
5.4 — 5.4
3.0 — 3.0
Astra Tech OsseoSpeedTM — 3.5/4.0 — 3.5/4.0
4.5/5.0 — 4.5/5.0
BioHorizons Internal — 3.0, 3.4, 3.8 — 3.0
3.8, 4.6 — 3.5
4.6, 5.8 — 4.5
5.8 — 5.7
Biomet 3i Certain® — 3.25 — 3.4
4.0 — 4.1
5.0 — 5.0
Biomet 3i OSSEOTITE® — 3.25 — 3.4
3.75, 4.0 — 4.1
5.0 — 5.0
Camlog — 3.3 — 3.3
3.8 — 3.8
4.3 — 4.3
5.0 — 5.0
Friadent XiVE® — 3.4 — 3.4
3.8 — 3.8
4.5 — 4.5
5.5 — 5.5
MegaGen AnyRidge — 3.5, 4.0, 4.5, 5.0, 5.5 — 3.5
Neodent Grand Morse — 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 — Grand Morse (GM)
3.0 — 3.0
NobelActive® — 3.5 — NP
NobelReplace/ NobelParallel Conical — 4.3, 5.0 — RP
5.5 — WP
NobelReplace® Trilobe — 3.5 — NP
4.3 — RP
5.0 — WP
6.0 — 6.0
Nobel Brånemark System® — 3.3 — NP
3.75, 4.0 — RP
5.0 — WP
Osstem TS — 3.5 — Mini
4.0, 4.5, 5.0, 6.0, 7.0 — Regular
Straumann® BLX — 3.5, 3.75, 4.0, 4.5 — RB
5.0, 5.5, 6.5 — WB
Straumann® Bone Level — 3.3 — NC
4.1, 4.8 — RC
Straumann® Tissue Level — 3.3 — NNC
3.3, 4.1, 4.8 — RN
4.8 — WN
Zimmer Screw-Vent® / Tapered Screw-Vent® — 3.3, 3.7, 4.1 — 3.5
4.7 — 4.5
6.0 — 5.7
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250639: 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/K250639
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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