# K111935: TI-Base Abutment, 1 Connect Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Nt-Trading GmbH and CO KG
- Decided: Feb 17, 2012 after 224 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). 43 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093483: Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment, Astra Tech, Inc. (2009) Summary page 1.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K080239: P.004 Abutments,  P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings, Straumann Manufacturing, Inc. (2008) Summary page 1.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K000152: Kippmed I.V. Manifold, The Kipp Group (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K083871: Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone, Astra Tech, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132219: Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN, Straumann (R) Variobase (TM) Abutment WN, (2014), 35 descendants of its own
- 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 (2015), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own

## Indications for use
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Ti-Base abutments are indicated for use with the following implant systems: * Nobel Biocare® Replace Select® * Nobel Biocare NobelActiveTM * Biomet 3i® Osseotite® * Biomet 3i® Osseotite® Certain® * Nobel Biocare Branemark® * Straumann® synOcta® * Straumann® Bone Level® * Zimmer® Tapered Screw-vent® * Astra Tech OsseoSpeed® * Dentsply-Friadent® Frialit® 2-CONnect Abutment for Bridges and Bars: 2-CONnect Abutment for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abutment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems: * Nobel Biocare® Replace Select® * Straumann® synOcta® * Straumann® BoneLevel®

Source page: https://510kreport.com/device/K111935
Methodology: https://510kreport.com/methodology
