# K150203: Medentika CAD/CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Oct 23, 2015 after 267 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: 13 generations back to K894844 (1990). 170 ancestors in all.
129 later devices descend from it; 14 cite it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 6.
- K052272: Straumann Computer Aided Restoration Service, Straumann USA (2006) Summary page 6.

## Most influential descendants
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## Indications for use
Medentika TiBase CAD/CAM 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. Implant System Compatibility — Series — Implant Diameter (mm) — Platform Diameter (mm) Nobel Biocare Replace™ Select — E — 3.5, 4.3, 5.0, 6.0 — 3.5, 4.3, 5.0, 6.0 Nobel Biocare NobelActive™ — F — 3.5, 4.3, 5.0 — 3.5, 3.9 (4.3), 3.9 (5.0) Biomet 3i Osseotite® Certain® — H — 3.25, 4.0, 5.0 — 3.4, 4.1, 5.0 Biomet 3i Osseotite® — I — 3.25, 3.75, 4.0, 5.0 — 3.4, 4.1, 5.0 Nobel Biocare Brånemark — K — 3.3, 3.75, 4.0, 5.0 — 3.5, 4.1, 4.1, 5.1 Straumann Bone Level — L — 3.3, 4.1, 4.8 — 3.3, 4.1, 4.8 Straumann Standard — N — 3.3, 4.1, 4.8 — 3.5( NNC), 4.8, 6.5 Zimmer Tapered Screw-vent® — R — 3.3, 3.7, 4.1, 4.7, 6.0 — 3.5, 4.5, 5.7 Astra Tech OsseoSpeed™ — S — 3.5, 4.0, 4.5, 5.0 — 3.5, 4.0, 4.5, 5.0 Dentsply Friadent® Frialit/XiVE® — T — 3.4, 3.8, 4.5, 5.5 — 3.4, 3.8, 4.5, 5.5 Dentsply Friadent® Ankylos® — Y — 3.5, 4.5, 5.5, 7.0 — 3.5, 4.5, 5.5, 7.0 Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. Medentika Preface CAD/CAM 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. Implant System Compatibility — Series — Implant Diameter (mm) — Platform Diameter (mm) Nobel Biocare Replace™ Select — E — 3.5, 4.3, 5.0, 6.0 — 3.5, 4.3, 5.0, 6.0 Nobel Biocare NobelActive™ — F — 3.0, 3.5, 4.3, 5.0 — 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) Biomet 3i Osseotite® Certain® — H — 3.25, 4.0, 5.0 — 3.4, 4.1, 5.0 Biomet 3i Osseotite® — I — 3.25, 3.75, 4.0, 5.0 — 3.4, 4.1, 5.0 Nobel Biocare Brånemark — K — 3.3, 3.75, 4.0, 5.0 — 3.5, 4.1, 4.1, 5.1 Straumann Bone Level — L — 3.3, 4.1, 4.8 — 3.3, 4.1, 4.8 Straumann Standard — N — 3.3, 4.1, 4.8 — 3.5( NNC), 4.8, 6.5 Zimmer Tapered Screw-vent® — R — 3.3, 3.7, 4.1, 4.7, 6.0 — 3.5, 4.5, 5.7 Astra Tech OsseoSpeed™ — S — 3.0, 3.5, 4.0, 4.5, 5.0 — 3.0, 3.5, 4.0, 4.5, 5.0 Dentsply Friadent® Frialit/XiVE® — T — 3.4, 3.8, 4.5, 5.5 — 3.4, 3.8, 4.5, 5.5 Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center.

Source page: https://510kreport.com/device/K150203
Methodology: https://510kreport.com/methodology