# K181037: DIO CAD/CAM Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Dec 21, 2018 after 246 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: 14 generations back to K894844 (1990). 217 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 4.
- K143505: Zimmer Patient-Specific Abutment, Internal Hex, Titanium, Zimmer Dental, Inc. (2015) Summary page 4.
- K112730: Abutment for Competitive Implant Straumann Bone Level Connection, Biomet 3i (2012) Summary page 4.

## Most influential descendants
- K222913: s-Clean Link Abutment (2023), 1 descendant of its own
- K210362: s-Clean Pre-Milled Abutment (2021), 1 descendant of its own
- K242703: LW Pre-milled Abutment (2024), 0 descendants of its own
- K232170: Ti Link Abutment (2024), 0 descendants of its own
- K230523: s-Clean Link Abutment Narrow (2023), 0 descendants of its own

## Indications for use
DIO CAD/CAM Abutment is 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 Implant Diameter (mm) Platform Diameter (mm) UF(II) Narrow Implant System 3.0/3.3 3.0/3.3 UF Sub merged Implant System 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 UF(II) Implant System 3.8/4.0/4.5/5.0/5.5 3.8/4.0/4.5/5.0/5.5 Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

Source page: https://510kreport.com/device/K181037
Methodology: https://510kreport.com/methodology