# K130808: Straumann Healing Abutments, Healing Caps, Closure Screws

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Jun 28, 2013 after 95 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: 10 generations back to K894595 (1990). 65 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System, Straumann USA (2011) Summary page 1.
- K072679: P.004 Abutments, Institut Straumann AG (2007) Summary page 1.
- K071585: P.004 Healing Abutments and Closure Screws, Straumann USA (2007) Summary page 1.
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap), Straumann Manufacturing, Inc. (2007)
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.
- K013798: Prosthetic Accessories to the Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K960634: Titanium Healing Caps, The Straumann Co. (1996) Summary page 1.
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.

## Most influential descendants
- K163194: Neodent Implant System - GM Line (2017), 30 descendants of its own
- K200992: S.I.N. Dental Implant System (2020), 7 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (2017), 5 descendants of its own
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own

## Indications for use
Closure Screws, healing caps, and healing abutments, are intended for use with the Straumann Dental implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Customizable healing abutments made of PEEK are for use for up to six months.

Source page: https://510kreport.com/device/K130808
Methodology: https://510kreport.com/methodology