# K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)

- Pathway: 510(k) (Traditional)
- Applicant: Straumann Manufacturing, Inc.
- Decided: Sep 20, 2007 after 212 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: 6 generations back to K894844 (1990). 15 ancestors in all.
283 later devices descend from it; 4 cite it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.
- K051717: RN Synocta Temporary Meso Abutment, Institut Straumann SA (2005) Summary page 1.

## Most influential descendants
- K072679: P.004 Abutments (2007), 279 descendants of its own
- K092814: Straumann Dental Abutments (2009), 223 descendants of its own
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own
- 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

## Indications for use
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.

Source page: https://510kreport.com/device/K070478
Methodology: https://510kreport.com/methodology