# K193425: Pre-Milled Blank

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Mar 9, 2020 after 90 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: 16 generations back to K894844 (1990). 173 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190299: Elos Accurate® Customized Abutment, Elos Medtech Pinol A/S (2019) Summary page 4.

## Most influential descendants
- K223634: Customized Abutment (2023), 3 descendants of its own
- K234112: Customized Abutment (2024), 1 descendant of its own
- K242768: Customized Abutment and Screw (2025), 0 descendants of its own
- K242245: Customized Abutment (2024), 0 descendants of its own

## Indications for use
ARUM Dentistry’s Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw. ARUM Dentistry’s Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table: All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.

Source page: https://510kreport.com/device/K193425
Methodology: https://510kreport.com/methodology