# K250178: Adin Customized Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Adin Dental Implant Systems, Ltd.
- Decided: Oct 17, 2025 after 268 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: 21 generations back to K960026 (1996). 337 ancestors in all.
No later device cites it as a predicate yet.
0 of 338 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221301: DESS Dental Smart Solutions, Terrats Medical SL (2023) Summary page 5.
- K223714: UniFit Dental Implant System, Adin Dental Implant Systems, Ltd. (2023) Summary page 5.
- K112585: Touareg Closefit Dental Impant System, Adin Dental Implants System, Ltd. (2012) Summary page 5.
- K081751: Adin Dental Implants System, Adin Dental Implants System, Ltd. (2008) Summary page 5.
- K223677: Titanium Abutment Blank Nobel Biocare N1 TCC, Nobel Biocare AB (2023) Summary page 6.
- K153111: TOUAREG CloseFit™ UNP 2.75mmD, Adin Dental Implants Systems, Ltd. (2016) Summary page 6.
- K140293: Touareg NP Closefit Dental Implants System, Adin Dental Implants Systems, Ltd. (2014) Summary page 6.

## Indications for use
Adin Customized Abutments are intended for use with Adin dental implants in partially or fully edentulous mandibles and maxillae, as a support for single-unit or multiple-unit screw-retained or cement-retained restorations. All digitally designed abutments for use with Adin Ti-base and Adin Ti-blanks are intended to be sent to an FDA-registered Adin Dental Implants validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: scans from desktop and intraoral scanners, CAD and CAM software and a milling machine with associated accessories.

Source page: https://510kreport.com/device/K250178
Methodology: https://510kreport.com/methodology