510(k) · Cleared
ClearedStraumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw
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 Apr 17, 2014 as substantially equivalent to K990342 (Straumann USA, 1999) and 3 other predicates after a 160-day review. Its family tree reaches back 9 generations to 1990. 115 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 160 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K894595 (1990). 70 ancestors in all, the oldest K894844 (1990). 115 later devices descend from it, 10 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- This deviceK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
- Descendant · cites it directly · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 3 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
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 backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- This deviceK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · cites it directly89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 3 generations on22descendants
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 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −2 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| 0 (this device) | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
| +1 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +3 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 22 | 0 |
| 2026 | 12 | 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? (4)
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 |
|---|---|---|---|
| * | K990342 | Synocta ProstheticsSummary page 1…dlosseous dental implant abutment (21 CER §872.3630) PROPRIETARY NAME Straumann Magellan Screw-Retained Abutment System PREDICATE DEVICES (K990342) Straumnatn synOcta screw-retained 1.5 mm Abutment Line (K080239)… | 1999 |
| * | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsSummary page 1…System PREDICATE DEVICES (K990342) Straumnatn synOcta screw-retained 1.5 mm Abutment Line (K080239) Straumann® RC/NC Bar and Bridge Abutment Line (K072071I) Strauma… | 2008 |
| * | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsSummary page 1…Abutment Line (K080239) Straumann® RC/NC Bar and Bridge Abutment Line (K072071I) Straumann® Bone Level Cementable Screw (KIO 1945) Neodent CM Exact Mini Angled Abutment DEVICE… | 2007 |
| * | K101945 | Neodent Implant System | 2011 |
What descends from it? (115)
See all 11510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150367 | Neodent Implant System | 2015 | 89 |
| K171757 | Straumann Screw Retained Abutments | 2017 | 14 |
| K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 | 5 |
| K192401 | Straumann Screw-Retained Abutments | 2020 | 2 |
| K141871 | Straumann Bone Level NC Angled Screw Retained Abutments | 2014 | 2 |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | 2023 | 0 |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | 2016 | 0 |
| K151247 | NC Straumann Screw Retained Abutments | 2015 | 0 |
| K150814 | Straumann Screw-Retained Abutment | 2015 | 0 |
| K140737 | Straumann Cares Screw Retained Bars/Bridge | 2014 | 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 24 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 70 ancestors have a recall of any class.
- Of its descendants, K150367 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2015) has gone furthest, with 89 descendants of its own.
- 13 other devices also cite its predicate K990342.
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?
The Straumann Magellan abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan abutments are indicated for screw-retained restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133421
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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