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 26, 2022 as substantially equivalent to K212628 (Terrats Medical SL, 2022) and 2 other predicates after a 90-day review. Its family tree reaches back 19 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 26, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K960026 (1996). 323 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK212577 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- This deviceK222269 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- Descendant · cites it directly · 1 of its ownK230143 DESS Dental Smart SolutionsTerrats Medical SL · 2023
- Descendant · cites it directly · 0 of its ownK260564 DESS Dental Smart SolutionsTerrats Medical SL · 2026
- Descendant · 2 generations on · 0 of its ownK231434 DESS Dental Smart SolutionsTerrats Medical SL · 2023
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 9 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 8 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 7 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 6 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 5 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 4 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK212577 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- This deviceK222269 DESS Dental Smart SolutionsTerrats Medical SL · 2022
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 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −9 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −8 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −7 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −6 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −5 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −1 | K212577 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| 0 (this device) | K222269 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| +1 | K230143 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 | — |
| +1 | K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026 | — |
| +2 | K231434 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 | — |
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 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 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 30.7 · 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? (3)
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 |
|---|---|---|---|
| * | K212628 | DESS Dental Smart SolutionsSummary page 4…iratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K212628, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K212577, DESS Dental Smart Solutions, Terrats Medical SL K191… | 2022 |
| * | K212577 | DESS Dental Smart SolutionsSummary page 4…Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K212628, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K212577, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K173908, DESS Dental Sm… | 2021 |
| * | K173908 | DESS Dental Smart SolutionsSummary page 4…Smart Solutions, Terrats Medical SL Reference Devices K212577, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K173908, DESS Dental Smart Solutions, Terrats Medical SL K201334, Keystone Dental XL Dental Implant System, Keystone Dental, Inc. === Pa… | 2018 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K201334 | Keystone Dental XL Dental Implant System | 2020 |
| † | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection… | 2005 |
| † | K072768 | Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants | 2007 |
| † | K101545 | Genesis Implant System | 2010 |
| † | K112795 | Paltop Dental Implant System | 2012 |
| † | K210117 | Paltop Narrow Implant | 2021 |
| † | K220200 | Paltop Conical Implant System | 2022 |
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 26 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 44 of the 323 ancestors have a recall of any class.
- Of its descendants, K230143 (Terrats Medical SL, 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K212628.
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?
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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems PRIMA CONNEX (Internal TiLobe, Tapered & Straight): Implant body diameter 3.3, 3.5 mm…
Read the full statement (285 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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
Compatible Implant Systems
PRIMA CONNEX (Internal TiLobe, Tapered & Straight): Implant body diameter 3.3, 3.5 mm; implant platform 3.5. Implant body diameter 4.0, 4.1 mm; implant platform 4.1. Implant body diameter 5.0 mm; implant platform 5.0.
GENESIS (Internal TiLobe): Implant body diameter 3.5, 3.8 mm; implant platform 3.5/3.8. Implant body diameter 4.5 mm; implant platform 4.5. Implant body diameter 5.5, 6.5 mm; implant platform 5.5/6.5.
MOLARIS TILOBEMAXX (Internal TiLobe): Implant body diameter 7 mm; implant platform 5.7. Implant body diameter 8 mm; implant platform 6.5. Implant body diameter 9 mm; implant platform 7.5.
MOLARIS I-HEXMRT (Internal Hex): Implant body diameter 7 mm; implant platform 5.7. Implant body diameter 8 mm; implant platform 6.5. Implant body diameter 9 mm; implant platform 7.5.
PALTOP ADVANCED CLASSIC (Internal Hex): Implant body diameter 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0).
PALTOP ADVANCED PLUS (Internal Hex): Implant body diameter 3.0, 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0). Implant body diameter 6.0 mm; implant platform WP (6.0).
PALTOP DYNAMIC (Internal Hex): Implant body diameter 3.0, 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0). Implant body diameter 6.0 mm; implant platform WP (6.0).
PALTOP DYNAMIC CONICAL (Internal Conical): Implant body diameter 3.25, 3.75, 4.2, 5.0 mm; implant platform CC (3.25/3.75/4.2/5.0).
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/K222269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222269: DESS Dental Smart Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222269
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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