# 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

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Mar 8, 2017 after 142 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894844 (1990). 261 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 5.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 6.
- K130808: Straumann Healing Abutments, Healing Caps, Closure Screws, Straumann USA (2013) Summary page 6.
- K092814: Straumann Dental Abutments, Straumann Manufacturing, Inc. (2009) Summary page 6.
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 6.
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit, Straumann USA, LLC (2015) Summary page 6.
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 6.
- K150899: Straumann CARES Titanium Alloy (TAN) Abutment, Straumann USA, LLC (2015) Summary page 6.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 6.

## Most influential descendants
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K192893: Straumann Ceramic Healing Abutments (2020), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own
- K232383: iPhysio® System (2025), 0 descendants of its own
- K173945: Straumann SC Variobase Abutments (2018), 0 descendants of its own

## Indications for use
Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ∅2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient’s jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Source page: https://510kreport.com/device/K162890
Methodology: https://510kreport.com/methodology