510(k) · Cleared
ClearedStraumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System
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 Oct 3, 2011 as substantially equivalent to K083550 (Straumann USA, 2009) and 5 other predicates after a 140-day review. Its family tree reaches back 9 generations to 1990. 222 later devices descend from it.
- Decided
- Oct 3, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K894595 (1990). 64 ancestors in all, the oldest K894844 (1990). 222 later devices descend from it, 8 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- This deviceK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · cites it directly · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · cites it directly · 122 of its ownK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- Descendant · cites it directly · 118 of its ownK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- This deviceK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 222 · See all- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · cites it directly166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K123784Straumann Dental Implant SystemStraumann USA, LLC · 2013 · cites it directly122descendants
- K130222Straumann Dental Implant SystemStraumann USA, LLC · 2013 · cites it directly118descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −1 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| 0 (this device) | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +1 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +1 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| +1 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
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 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 10 | 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? (6)
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 |
|---|---|---|---|
| * | K083550 | Straumann Dental Implant SystemSummary page 1…oot-form Regulation Number: §872.3640 1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K083550, Straumann Dental Implant System K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Ab… | 2009 |
| * | K060958 | Straumann Narrow Neck ImplantsSummary page 1…3640 1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K083550, Straumann Dental Implant System K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Abutment for Crowns K092814, Straumann NC T… | 2006 |
| * | K072497 | P.004 NC Gold Abutment for CrownsSummary page 1…nce is Claimed (Predicate Device) K083550, Straumann Dental Implant System K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Abutment for Crowns K092814, Straumann NC Temporary Abutments K(071585, NC Closure Screws… | 2007 |
| * | K092814 | Straumann Dental AbutmentsSummary page 1…K083550, Straumann Dental Implant System K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Abutment for Crowns K092814, Straumann NC Temporary Abutments K(071585, NC Closure Screws K960634, Esthetic Healing Caps 5.… | 2009 |
| * | K071585 | P.004 Healing Abutments and Closure ScrewsSummary page 1…K060958, Straumann Narrow Neck Dental Implants K072497, P.004 NC Gold Abutment for Crowns K092814, Straumann NC Temporary Abutments K(071585, NC Closure Screws K960634, Esthetic Healing Caps 5. Description of the Device The proposed St… | 2007 |
| * | K960634 | Titanium Healing CapsSummary page 1…Implants K072497, P.004 NC Gold Abutment for Crowns K092814, Straumann NC Temporary Abutments K(071585, NC Closure Screws K960634, Esthetic Healing Caps 5. Description of the Device The proposed Straumann Narrow Neck Connection CrossFit… | 1996 |
What descends from it? (222)
See all 2228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC… | 2011 | 166 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
| K130222 | Straumann Dental Implant System | 2013 | 118 |
| K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 | 39 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | 2015 | 6 |
| K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary… | 2012 | 1 |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | 2019 | 0 |
| K113606 | NNC Gold Abutment for Bridges | 2012 | 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 21 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 64 ancestors have a recall of any class.
- Of its descendants, K113283 (Straumann USA, 2011) has gone furthest, with 166 descendants of its own.
- 8 other devices also cite its predicate K083550.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann®)dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate…
Read the full statement (274 words)
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann®)dental implants can also be used 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 by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
The Straumann NNC Temporary Abutments are indicated for use in Straumann NNC Tissue Level Implants for temporary restorations of single crowns and bridges for up to six months.
Straumann NNC Healing Caps and NNC Closure Screws are intended for use with the Straumann NNC Tissue Level Implant system to protect the inner configuration of the implant. Healing Caps have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
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/K111357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM 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/K111357
Report an extraction error
Are you the manufacturer?
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