510(k) · Cleared
ClearedStraumann Narrow Neck Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Aug 24, 2006 as substantially equivalent to K010291 (Straumann USA, 2001) and 6 other predicates after a 139-day review. Its family tree reaches back 8 generations to 1990. 228 later devices descend from it.
- Decided
- Aug 24, 2006
- Review
- 139 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K894595 (1990). 45 ancestors in all, the oldest K894844 (1990). 228 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 1 generation backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- This deviceK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- Descendant · cites it directly · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 2 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · 3 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 4 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 2 generations on · 122 of its ownK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 228 · See all- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · cites it directly222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 2 generations on166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 3 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 4 generations on129descendants
- K123784Straumann Dental Implant SystemStraumann USA, LLC · 2013 · 2 generations on122descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −1 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| 0 (this device) | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| +1 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +2 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +4 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +2 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 11 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 18 | 0 |
| 2021 | 24 | 0 |
| 2022 | 16 | 0 |
| 2023 | 29 | 0 |
| 2024 | 30 | 0 |
| 2025 | 27 | 0 |
| 2026 | 16 | 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? (7)
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 |
|---|---|---|---|
| * | K010291 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Implants, originally cleared under K01 0291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture M… | 2001 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Implants, originally cleared under K01 0291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro… | 2003 |
| * | K053088 | Slactive ImplantsSummary page 1…72.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann Implants, originally cleared under K01 0291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K0241 11… | 2006 |
| * | K021318 | Xive Dental Implant SystemSummary page 1…ivalence is Claimed (Predicate Devices) Straumann Implants, originally cleared under K01 0291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K0241 11 Nobelbiocare Replace Select Straight Dental Im… | 2002 |
| * | K024111 | Astra Tech Implants-Dental System Fixture OsseospeedSummary page 1…inally cleared under K01 0291, K030007 and K053088 Friadent XiVE Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K0241 11 Nobelbiocare Replace Select Straight Dental Implants, K022562 and K023113 4. Description of the Device T… | 2003 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…E Dental Implant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K0241 11 Nobelbiocare Replace Select Straight Dental Implants, K022562 and K023113 4. Description of the Device The Straumann Narrow Neck Implants are intended for surgical placement i… | 2002 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…lant System, K021318 Astra Tech Implants - Dental System Fixture MicroMacro, K0241 11 Nobelbiocare Replace Select Straight Dental Implants, K022562 and K023113 4. Description of the Device The Straumann Narrow Neck Implants are intended for surgical placement in the maxill… | 2002 |
What descends from it? (228)
See all 2282 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 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K111357 (Straumann USA, 2011) has gone furthest, with 222 descendants of its own.
- 2 other devices also cite its predicate K010291.
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 Narrow Neck implants are intended for single-stage or two-stage surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.
Straumann Narrow Neck implants are intended for immediate 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 in immediately loaded cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060958: Straumann Narrow Neck Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060958
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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