# K080239: P.004 Abutments,  P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings

- Pathway: 510(k) (Traditional)
- Applicant: Straumann Manufacturing, Inc.
- Decided: Apr 30, 2008 after 90 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: 5 generations back to K894844 (1990). 13 ancestors in all.
164 later devices descend from it; 4 cite it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.
- K994119: Synocta Angled Abutments, Straumann USA (2000) Summary page 1.
- K962023: Plastic Protection Healing Caps, The Straumann Co. (1996) Summary page 1.
- K051717: RN Synocta Temporary Meso Abutment, Institut Straumann SA (2005) Summary page 1.
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System, Straumann USA (2002) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.

## Most influential descendants
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw (2014), 115 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
- K111935: TI-Base Abutment, 1 Connect Abutment (2012), 64 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 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. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. 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. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.

Source page: https://510kreport.com/device/K080239
Methodology: https://510kreport.com/methodology