510(k) · Cleared
ClearedStraumann Dental Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Aug 11, 2006 as substantially equivalent to K033922 (Institut Straumann AG, 2004) and 2 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1990. 148 later devices descend from it.
- Decided
- Aug 11, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894595 (1990). 18 ancestors in all. 148 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK030007 Iti Dental Implant SystemStraumann USA · 2003
- 1 generation backK033922 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · Recalled
- This deviceK061176 Straumann Dental ImplantsInstitut Straumann AG · 2006
- Descendant · cites it directly · 104 of its ownK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- Descendant · 2 generations on · 75 of its ownK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- Descendant · 3 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · 3 generations on · 42 of its ownK130662 ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · Recalled
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 148 · See all- K101096HT Iii SA Fixture SystemHiossen, Inc. · 2010 · cites it directly104descendants
- K120847ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012 · 2 generations on75descendants
- K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · 2 generations on64descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 3 generations on44descendants
- K130662ET Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K030007 | Iti Dental Implant System | Straumann USA | 2003 | — |
| −1 | K033922 | Modification to Iti Dental Implant System | Institut Straumann AG | 2004 | 1 |
| 0 (this device) | K061176 | Straumann Dental Implants | Institut Straumann AG | 2006 | — |
| +1 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| +2 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| +3 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +3 | K130662 | ET Prosthetic System | Osstem Implant Co., Ltd. | 2014 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 11 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 24 | 0 |
| 2024 | 22 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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? (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 |
|---|---|---|---|
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 1…2.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann RN Dental Implants, originally cleared under K033922 and K030007 Straumann NN Implants, originally cleared under K010291 and K030007 4. Description of the Device… | 2004 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann RN Dental Implants, originally cleared under K033922 and K030007 Straumann NN Implants, originally cleared under K010291 and K030007 4. Description of the Device The… | 2003 |
| * | K010291 | Iti Dental Implant SystemSummary page 1…edicate Devices) Straumann RN Dental Implants, originally cleared under K033922 and K030007 Straumann NN Implants, originally cleared under K010291 and K030007 4. Description of the Device The Straumann Dental Implant with anodized neck is a minor modificatio… | 2001 |
What descends from it? (148)
See all 1485 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 16 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K101096 (Hiossen, Inc., 2010) has gone furthest, with 104 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.
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 Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical…
Read the full statement (191 words)
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery.
The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061176: Straumann Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061176
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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