510(k) · Cleared
Recalled · Class II · 2025Straumann® Anatomic Healing Abutments XC (AHA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 11, 2024 as substantially equivalent to K130808 (Straumann USA, 2013) after a 161-day review. Its family tree reaches back 11 generations to 1990. It has been recalled once.
- Decided
- Nov 11, 2024
- Review
- 161 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 66 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- This deviceK241575 Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC · 2024
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 4 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 3 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 2 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 1 generation backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- This deviceK241575 Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −4 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −3 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −1 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| 0 (this device) | K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K130808 | Straumann Healing Abutments, Healing Caps, Closure ScrewsSummary page 6…K241575 Product Code(s): NHA Classification Panel: Dental Predicate Device(s) Primary Predicate: x Straumann Healing Abutments (K130808) Reference Devices: x BellaTek Encode Emergence Healing Abutment (K212730) x Protective caps of the Straumann Magell… | 2013 |
| † | K212730 | BellaTek Encode Emergence Healing Abutments | 2021 |
| † | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw | 2014 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2025 | Class II | Z-1671-2025 | Under Investigation by firm | Incorrect blister labelling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 66 ancestors have a recall of any class.
- 4 other devices also cite its predicate K130808.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241575 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241575: Straumann® Anatomic Healing Abutments XC (AHA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241575
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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