# K142167: Medentika Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Feb 20, 2015 after 198 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: 12 generations back to K894595 (1990). 210 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162, Nobel Biocare Uas, Inc. (2002) Summary page 5.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 5.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 5.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 5.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 5.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 5.
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 5.
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 5.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 5.
- K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 6.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 6.
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems, Nobel Biocare AB (2010) Summary page 6.
- K072878: Modification to: Locator Implant Anchor, Zest Anchors, Inc. (2007) Summary page 6.
- K092434: Sterngold 2.2MM Angles Micro Era Dental Implant System, Sterngold (2009) Summary page 6.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 6.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 6.
- K080239: P.004 Abutments,  P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings, Straumann Manufacturing, Inc. (2008) Summary page 6.

## Most influential descendants
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (2024), 3 descendants of its own
- K180564: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (2019), 2 descendants of its own
- K191111: DD Solid Connect® CAD/CAM Abutments (2023), 1 descendant of its own
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (2026), 0 descendants of its own
- K253341: Custom Abutments AS (2025), 0 descendants of its own

## Indications for use
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Abutments are compatible with the following implant systems: Nobel Biocare Replace Select, E-Series, implant diameters 3.5, 4.3, 5.0, 6.0 mm Nobel Biocare NobelActive, F-Series, implant diameters 3.5, 4.3, 5.0 mm Biomet 3i Osseotite Certain, H-Series, implant diameters 3.25, 4.0, 5.0 mm Biomet 3i Osseotite, I-Series, implant diameters 3.25, 3.75, 4.0, 5.0 mm Nobel Biocare Branemark, K-Series, implant diameters 3.3, 3.75, 4.0, 5.0 mm Straumann Bone Level, L-Series, implant diameters 3.3, 4.1, 4.8 mm Straumann Standard, N-Series, implant diameters 3.3, 4.1, 4.8 mm Zimmer Tapered Screw-vent, R-Series, implant diameters 3.3, 3.7, 4.1, 4.7, 6.0 mm Astra Tech OsseoSpeed, S-Series, implant diameters 3.5, 4.0, 4.5, 5.0 mm Dentsply Friadent Frialit/Xive, T-Series, implant diameters 3.4, 3.8, 4.5, 5.5 mm Dentsply Friadent Ankylos, Y-Series, implant diameters 3.5, 4.5, 5.5, 7.0 mm

Source page: https://510kreport.com/device/K142167
Methodology: https://510kreport.com/methodology