# K153111: TOUAREG CloseFit™ UNP 2.75mmD

- Pathway: 510(k) (Traditional)
- Applicant: Adin Dental Implants Systems, Ltd.
- Decided: May 6, 2016 after 191 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 K080396 (2008). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140293: Touareg NP Closefit Dental Implants System, Adin Dental Implants Systems, Ltd. (2014) Summary page 5.

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

## Indications for use
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When an one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. The TOUAREG CloseFit™ UNP 2.75mmD Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

Source page: https://510kreport.com/device/K153111
Methodology: https://510kreport.com/methodology