510(k) · Cleared
ClearedNNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 13, 2012 as substantially equivalent to K894844 (Straumann Institute, Ltd., 1990) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Jan 13, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894844 (1990). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 6 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 5 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 4 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 3 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 2 generations backK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
- 1 generation backK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
- This deviceK113410 NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC…Straumann USA · 2012
- Descendant · cites it directly · 0 of its ownK251220 NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −6 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −5 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −4 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −3 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −2 | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | Institut Straumann AG | 2007 | — |
| −1 | K080286 | Cementable Abuntments; Temporary Copings; Protective Caps | Straumann USA | 2008 | — |
| 0 (this device) | K113410 | NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap… | Straumann USA | 2012 | — |
| +1 | K251220 | NUVENTUS NV.C™ Prosthetic Components | Infinitum Eta, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…on Number: §872.3630 4. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Regular Neck (RN) Solid Abutment, K894844 Straumann Narrow Connection (NC) Temporary Copings, and Straumann Narrow Connection (NC) Protective Caps, K080286 5… | 1990 |
| * | K080286 | Cementable Abuntments; Temporary Copings; Protective CapsSummary page 1…raumann Regular Neck (RN) Solid Abutment, K894844 Straumann Narrow Connection (NC) Temporary Copings, and Straumann Narrow Connection (NC) Protective Caps, K080286 5. Description of the Device Straumann Narrow Neck CrossFit (NNC) Solid Abutments are permanent abutments int… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251220 | NUVENTUS NV.C™ Prosthetic Components | 2025 | 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 22 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K251220 (Infinitum Eta, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K894844.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations. Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for…
Read the full statement (123 words)
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations.
Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days.
Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113410: NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113410
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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