510(k) · Cleared
ClearedAbutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator Abutment, Solid Abutment, Retentive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager& Meisinger GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 7, 2014 as substantially equivalent to K091701 (Institut Straumann AG, 2009) and 1 other predicate after a 356-day review. Its family tree reaches back 7 generations to 1990. 9 later devices descend from it.
- Decided
- Jul 7, 2014
- Review
- 356 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894844 (1990). 12 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 5 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 4 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 3 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 2 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 1 generation backK091701 Straumann Modified Dental AbutmentInstitut Straumann AG · 2009
- This deviceK132214 Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive…Hager& Meisinger GmbH · 2014
- Descendant · cites it directly · 8 of its ownK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- Descendant · 2 generations on · 3 of its ownK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 1 of its ownK170287 Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017
- Descendant · 4 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015 · cites it directly8descendants
- K173819MyPlant II Implant SystemHager& Meisinger GmbH · 2018 · 2 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
- K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017 · 2 generations on1descendant
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −5 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −4 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −3 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −2 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −1 | K091701 | Straumann Modified Dental Abutment | Institut Straumann AG | 2009 | — |
| 0 (this device) | K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base… | Hager& Meisinger GmbH | 2014 | — |
| +1 | K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015 | — |
| +2 | K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | 2017 | — |
| +4 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.6 · 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 |
|---|---|---|---|
| * | K091701 | Straumann Modified Dental AbutmentSummary page 1…Dental 4. Predicate Devices: 510(k No.) Manufacturer Trade Name K091 701 Straumann Dental Abutment (Modified Dental… | 2009 |
| * | K073628 | Synocta AbutmentsSummary page 1…umann Dental Abutment (Modified Dental Implant Abutment) K073628 Straumann Abutment, Dental, Endosseous… | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143539 | Dental Implant OKTAGON Bone Level | 2015 | 8 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K143539 (Hager& Meisinger GmbH, 2015) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K091701.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can Include individual crowns, bridges, partial or total prostheses. Abutments can be used in single tooth replacements and multiple tooth restorations. The Dental Implant Abutments OKTAGONO are Intended to be compatible to OIKTAGONO implants (Dental Implant OKTAGONO) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132214: Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator Abutment, Solid Abutment, Retentive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132214
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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