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 Mar 11, 2022 as substantially equivalent to K170588 (Terrats Medical SL, 2017) and 2 other predicates after a 204-day review. Its family tree reaches back 18 generations to 1996. 20 later devices descend from it.
- Decided
- Mar 11, 2022
- Review
- 204 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K960026 (1996). 321 ancestors in all, the oldest K781060 (1978). 20 later devices descend from it, 5 citing it directly.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- Descendant · cites it directly · 14 of its ownK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- Descendant · 2 generations on · 3 of its ownK242340 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- Descendant · 2 generations on · 3 of its ownK240982 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- Descendant · 2 generations on · 3 of its ownK221301 DESS Dental Smart SolutionsTerrats Medical SL · 2023
- Descendant · cites it directly · 3 of its ownK222269 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 1 generation backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- This deviceK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K222288DESS Dental Smart SolutionsTerrats Medical SL · 2022 · cites it directly14descendants
- K242340DESS Dental Smart SolutionsTerrats Medical SL · 2024 · 2 generations on3descendants
- K240982DESS Dental Smart SolutionsTerrats Medical SL · 2024 · 2 generations on3descendants
- K221301DESS Dental Smart SolutionsTerrats Medical SL · 2023 · 2 generations on3descendants
- K222269DESS Dental Smart SolutionsTerrats Medical SL · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −1 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| 0 (this device) | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| +1 | K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| +2 | K242340 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| +2 | K240982 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| +2 | K221301 | DESS Dental Smart Solutions | Terrats Medical SL | 2023 | — |
| +1 | K222269 | 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 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K170588 | DESS Dental Smart SolutionsSummary page 4…NHA Classification Panel Dental Products Panel Reviewing Division DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K173908, DESS Dental Smart Solutions, Terrats Medical SL K191… | 2017 |
| * | K173908 | DESS Dental Smart SolutionsSummary page 4…DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K173908, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL 510(k)… | 2018 |
| * | K191986 | DESS Dental Smart SolutionsSummary page 4…INFORMATION Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K173908, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL 510(k) Summary… | 2019 |
| † | K111287 | Astra Tech Implant System | 2011 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K042429 | The Prodigy System Dental Implants | 2004 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
What descends from it? (20)
See all 205 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 321 ancestors have a recall of any class.
- Of its descendants, K222288 (Terrats Medical SL, 2022) has gone furthest, with 14 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. 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.
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/K212628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212628: 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/K212628
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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