510(k) · Cleared
ClearedDESS® Dental Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terrats Medical SL · DZE Implant, Endosseous, Root-Form
Cleared on Jul 23, 2025 as substantially equivalent to K212538 (Terrats Medical SL, 2021) after a 90-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Jul 23, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 146 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 1 generation backK212538 DESS Dental ImplantsTerrats Medical SL · 2021
- This deviceK251280 DESS® Dental ImplantsTerrats Medical SL · 2025
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 11 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 10 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 8 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 7 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 6 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 5 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 4 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 3 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 1 generation backK212538 DESS Dental ImplantsTerrats Medical SL · 2021
- This deviceK251280 DESS® Dental ImplantsTerrats Medical SL · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −11 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −10 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −8 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −7 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −6 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −5 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −4 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −3 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −2 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| −1 | K212538 | DESS Dental Implants | Terrats Medical SL | 2021 | — |
| 0 (this device) | K251280 | DESS® Dental Implants | Terrats Medical SL | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K212538 | DESS Dental ImplantsSummary page 6…espiratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE AND REFERENCE DEVICE INFORMATION Primary Predicate Device K212538, DESS® Dental Implants, Terrats Medical SL Reference Devices K143353, Hahn Tapered Implant System, Prismatik Dentalcraft, Inc. K… | 2021 |
| † | K143353 | Hahn Tapered Implant System | 2015 |
| † | K242340 | DESS Dental Smart Solutions | 2024 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
| † | K240208 | DESS Dental Smart Solutions | 2024 |
| † | K222288 | DESS Dental Smart Solutions | 2022 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
| † | K243212 | DESS Dental Smart Solutions | 2025 |
| † | K233316 | DESS Dental Smart Solutions | 2024 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K111287 | Astra Tech Implant System | 2011 |
| † | K042429 | The Prodigy System Dental Implants | 2004 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K180282 | MIS Internal Hex Dental Implant System | 2018 |
| † | K142260 | NobelActive | 2015 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K210499 | Alpha Dent Implants Dental Implants System | 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 35 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 19 of the 146 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation…
Read the full statement (225 words)
DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for
anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or
multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental
implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate
or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is
appropriate.
DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM
connection manufactured by Terrats Medical SL.
DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not
enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior
region of the mouth.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251280: DESS® Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251280
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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