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 Apr 29, 2013 as substantially equivalent to K033922 (Institut Straumann AG, 2004) and 9 other predicates after a 90-day review. Its family tree reaches back 11 generations to 1990. 118 later devices descend from it.
- Decided
- Apr 29, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 11 generations to K894595 (1990). 70 ancestors in all, the oldest K894844 (1990). 118 later devices descend from it, 9 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- Descendant · cites it directly · 105 of its ownK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 4 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · cites it directly105descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −4 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −3 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −1 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| 0 (this device) | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| +1 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 11 | 0 |
| 2023 | 17 | 0 |
| 2024 | 17 | 0 |
| 2025 | 24 | 0 |
| 2026 | 13 | 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? (10)
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 |
|---|---|---|---|
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 1…duct Families Common Name: Dental Implants Classification Name: Implant, Endosseous, Root-form Regulation Number: §872.3640 5.2 Predicate Device(s) K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants… | 2004 |
| * | K033984 | Straumann Dental Implant SystemSummary page 1…plants Classification Name: Implant, Endosseous, Root-form Regulation Number: §872.3640 5.2 Predicate Device(s) K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified… | 2004 |
| * | K053088 | Slactive ImplantsSummary page 1…t, Endosseous, Root-form Regulation Number: §872.3640 5.2 Predicate Device(s) K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Nec… | 2006 |
| * | K062129 | P.0004 ImplantsSummary page 1…gulation Number: §872.3640 5.2 Predicate Device(s) K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm De… | 2006 |
| * | K081419 | Straumann Dental Implant SystemSummary page 1…40 5.2 Predicate Device(s) K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm Dental Implant System K121… | 2009 |
| * | K083550 | Straumann Dental Implant SystemSummary page 1…K033922, Modification to ITI Dental Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm Dental Implant System K121131, Straumann Bone Level 04.1 mm… | 2009 |
| * | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemSummary page 1…al Implant System K033984, ITI Dental Implant System K053088, SLActive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm Dental Implant System K121131, Straumann Bone Level 04.1 mm and 04.8 mm Regular Connection (R… | 2011 |
| * | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMSummary page 1…ive Implants K062129, P.004 Implants K081419, Modified Dental Implant K083550, Modified Dental Implant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm Dental Implant System K121131, Straumann Bone Level 04.1 mm and 04.8 mm Regular Connection (RC) Roxolid Dental Implants K122855, Straumann Tissue Level 04.1 mm… | 2012 |
| * | K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsSummary page 1…lant K1 11357, Narrow Neck CrossFit (NNC) 03.3 mm Dental Implant System K121131, Straumann Bone Level 04.1 mm and 04.8 mm Regular Connection (RC) Roxolid Dental Implants K122855, Straumann Tissue Level 04.1 mm and 04.8 mm Roxolid Dental Implants K123784, Straumann Dental Implant System - SLA, SLActive and… | 2012 |
| * | K123784 | Straumann Dental Implant System Cleared while this submission was under review Summary page 1…131, Straumann Bone Level 04.1 mm and 04.8 mm Regular Connection (RC) Roxolid Dental Implants K122855, Straumann Tissue Level 04.1 mm and 04.8 mm Roxolid Dental Implants K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families Traditional 510(k) St… | 2013 |
What descends from it? (118)
See all 1189 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140878 | Straumann Bone Level Tapered Implant | 2014 | 105 |
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K171784 | Straumann Dental Implant System | 2018 | 4 |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 2022 | 1 |
| K231566 | ICX-Implant System | 2024 | 0 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech… | 2024 | 0 |
| K202942 | Straumann 4 mm Short Implants | 2021 | 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 23 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 70 ancestors have a recall of any class.
- Of its descendants, K140878 (Straumann USA, LLC, 2014) has gone furthest, with 105 descendants of its own.
- 9 other devices also cite its predicate K033922.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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 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/K130222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130222: 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/K130222
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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