510(k) · Cleared
ClearedStraumann Modified Dental Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 22, 2009 as substantially equivalent to K062129 (Institut Straumann AG, 2006) after a 195-day review. Its family tree reaches back 6 generations to 1990. 11 later devices descend from it.
- Decided
- Dec 22, 2009
- Review
- 195 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894844 (1990). 9 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 4 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 3 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 2 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 1 generation backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- This deviceK091701 Straumann Modified Dental AbutmentInstitut Straumann AG · 2009
- Descendant · cites it directly · 9 of its ownK132214 Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive…Hager& Meisinger GmbH · 2014
- Descendant · 2 generations on · 8 of its ownK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- Descendant · 3 generations on · 3 of its ownK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
- Descendant · 4 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 3 generations on · 1 of its ownK170287 Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH · 2014 · cites it directly9descendants
- K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015 · 2 generations on8descendants
- K173819MyPlant II Implant SystemHager& Meisinger GmbH · 2018 · 3 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 4 generations on2descendants
- K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −4 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −3 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −2 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −1 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| 0 (this device) | K091701 | Straumann Modified Dental Abutment | Institut Straumann AG | 2009 | — |
| +1 | K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base… | Hager& Meisinger GmbH | 2014 | — |
| +2 | K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015 | — |
| +3 | K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018 | — |
| +4 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +3 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 30.7 · 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? (1)
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 |
|---|---|---|---|
| * | K062129 | P.0004 ImplantsSummary page 1…er: 21 CFR §872.3630 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Dental Implant Abutment, K062129 4. Description of the Device The Straumann Dental Implant System is an integrated system of endosseous denta… | 2006 |
What descends from it? (11)
See all 112 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 19 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K132214 (Hager& Meisinger GmbH, 2014) has gone furthest, with 9 descendants of its own.
- 30 other devices also cite its predicate K062129.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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.
Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091701: Straumann Modified Dental Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091701
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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