# K191123: Multi-unit Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Jan 6, 2020 after 252 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: 11 generations back to K894595 (1990). 72 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171757: Straumann Screw Retained Abutments, Straumann USA, LLC (On Behalf of Institut Straumann Ag) (2017) Summary page 5.

## Most influential descendants
- K203252: Multi-unit Abutments for CONELOG (2021), 8 descendants of its own
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components (2022), 3 descendants of its own
- K240187: Tapered Pro Conical Implant System (2024), 2 descendants of its own
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (2023), 2 descendants of its own
- K260061: BioHorizons CEREC Compatible Ti-Bases (2026), 0 descendants of its own

## Indications for use
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. Multi-unit Abutments are used for the restoration of the following dental implant systems: Medentika series | Implant system | Implant diameter | Platform diameter EV-Series | Dentsply® Implants - ASTRA TECH OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 F-Series | Nobel Biocare NobelActive - NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5

Source page: https://510kreport.com/device/K191123
Methodology: https://510kreport.com/methodology