510(k) · Cleared
ClearedStraumann Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jan 19, 2018 as substantially equivalent to K130222 (Straumann USA, LLC, 2013) after a 218-day review. Its family tree reaches back 12 generations to 1990. 4 later devices descend from it.
- Decided
- Jan 19, 2018
- Review
- 218 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 71 ancestors in all, the oldest K894844 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK171784 Straumann Dental Implant SystemStraumann USA, LLC · 2018
- Descendant · cites it directly · 1 of its ownK212538 DESS Dental ImplantsTerrats Medical SL · 2021
- Descendant · 2 generations on · 0 of its ownK251280 DESS® Dental ImplantsTerrats Medical SL · 2025
- Descendant · cites it directly · 0 of its ownK223083 Straumann SLActive labeling changesInstitut Straumann AG · 2023
- Descendant · cites it directly · 0 of its ownK202095 CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 9 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 6 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 5 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 4 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK171784 Straumann Dental Implant SystemStraumann USA, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K212538DESS Dental ImplantsTerrats Medical SL · 2021 · cites it directly1descendant
- K251280DESS® Dental ImplantsTerrats Medical SL · 2025 · 2 generations on0descendants
- K223083Straumann SLActive labeling changesInstitut Straumann AG · 2023 · cites it directly0descendants
- K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −9 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −6 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −5 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −2 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −1 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| 0 (this device) | K171784 | Straumann Dental Implant System | Straumann USA, LLC | 2018 | — |
| +1 | K212538 | DESS Dental Implants | Terrats Medical SL | 2021 | — |
| +2 | K251280 | DESS® Dental Implants | Terrats Medical SL | 2025 | — |
| +1 | K223083 | Straumann SLActive labeling changes | Institut Straumann AG | 2023 | — |
| +1 | K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K130222 | Straumann Dental Implant SystemSummary page 4…us, Root-form Regulatory Class: DZE Product Code: Class II (21 CFR 872.3640) 5.3 Predicate Device Primary Predicate: Straumann® Dental Implant System (K130222) Reference Predicate: Straumann® Bone Level Tapered Implants (K140878) Straumann® Bone Level Tapered Impla… | 2013 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K153758 | Straumann Bone Level Tapered Implants | 2016 |
What descends from it? (4)
3 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 28 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 71 ancestors have a recall of any class.
- Of its descendants, K212538 (Terrats Medical SL, 2021) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K130222.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary…
Read the full statement (99 words)
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171784: Straumann Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171784
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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