# K080286: Cementable Abuntments; Temporary Copings; Protective Caps

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Mar 7, 2008 after 32 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: 7 generations back to K894844 (1990). 16 ancestors in all.
179 later devices descend from it; 4 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072071: Straumann P.004 Cementable Abutments, Temporary Copings  and Protective Caps, Institut Straumann AG (2007) Summary page 1.

## Most influential descendants
- K113283: NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC Basal Screw  Cementable Abutments (2011), 166 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Indications for use
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.

Source page: https://510kreport.com/device/K080286
Methodology: https://510kreport.com/methodology