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 Dec 14, 2021 as substantially equivalent to K142260 (Nobel Biocare AB, 2015) and 4 other predicates after a 124-day review. Its family tree reaches back 13 generations to 1990. 1 later device descends from it.
- Decided
- Dec 14, 2021
- Review
- 124 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K894595 (1990). 145 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- This deviceK212538 DESS Dental ImplantsTerrats Medical SL · 2021
- Descendant · cites it directly · 0 of its ownK251280 DESS® Dental ImplantsTerrats Medical SL · 2025
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 10 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 7 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 6 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 5 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 4 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- This deviceK212538 DESS Dental ImplantsTerrats Medical SL · 2021
Most influential descendants
Showing 1 of 1 · See all- K251280DESS® Dental ImplantsTerrats Medical SL · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −10 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −7 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −6 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −5 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −3 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −2 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −1 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| 0 (this device) | K212538 | DESS Dental Implants | Terrats Medical SL | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K142260 | NobelActiveSummary page 4…DZE Classification Panel Dental Products Panel Reviewing Division DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K142260, NobelActive®, Nobel Biocare AB Additional Predicate Devices K140878, Straumann® Bone Level Tapered Implants Titanium SLA, Strau… | 2015 |
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 4…ision DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K142260, NobelActive®, Nobel Biocare AB Additional Predicate Devices K140878, Straumann® Bone Level Tapered Implants Titanium SLA, Straumann USA, LLC K171784, Straumann® Dental Implant System, Straumann USA… | 2014 |
| * | K171784 | Straumann Dental Implant SystemSummary page 4…y Predicate Device K142260, NobelActive®, Nobel Biocare AB Additional Predicate Devices K140878, Straumann® Bone Level Tapered Implants Titanium SLA, Straumann USA, LLC K171784, Straumann® Dental Implant System, Straumann USA, LLC K212125, Nobel Biocare Dental Implant Systems Portfolio - MR Conditional. N… | 2018 |
| * | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional Cleared while this submission was under review Summary page 4…ditional Predicate Devices K140878, Straumann® Bone Level Tapered Implants Titanium SLA, Straumann USA, LLC K171784, Straumann® Dental Implant System, Straumann USA, LLC K212125, Nobel Biocare Dental Implant Systems Portfolio - MR Conditional. Nobel Biocare AG K023113, Replace TiUnite Endosseous Implant, N… | 2021 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 4…raumann USA, LLC K171784, Straumann® Dental Implant System, Straumann USA, LLC K212125, Nobel Biocare Dental Implant Systems Portfolio - MR Conditional. Nobel Biocare AG K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA Inc. Page 1 of 6 === Page 5 =… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251280 | DESS® Dental Implants | 2025 | 0 |
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 31 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 145 ancestors have a recall of any class.
- Of its descendants, K251280 (Terrats Medical SL, 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K142260.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 (153 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. Implants of diameter 3.0 mm, 3.3 mm and 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 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.
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/K212538 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212538: 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/K212538
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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