# K223714: UniFit Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Adin Dental Implant Systems, Ltd.
- Decided: Dec 29, 2023 after 382 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081751 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112585: Touareg Closefit Dental Impant System, Adin Dental Implants System, Ltd. (2012) Summary page 6.

## Most influential descendants
- K250178: Adin Customized Abutments (2025), 0 descendants of its own

## Indications for use
UniFit Dental Implant System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. UniFit short implants (6 mm L) are intended to be used only with straight abutments. All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.

Source page: https://510kreport.com/device/K223714
Methodology: https://510kreport.com/methodology