# K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Apr 17, 2014 after 160 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 70 ancestors in all.
115 later devices descend from it; 10 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K080239: P.004 Abutments,  P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings, Straumann Manufacturing, Inc. (2008) Summary page 1.
- K072071: Straumann P.004 Cementable Abutments, Temporary Copings  and Protective Caps, Institut Straumann AG (2007) Summary page 1.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011)

## Most influential descendants
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K133421
Methodology: https://510kreport.com/methodology