TOUAREG CloseFit UNP 2.75mmD
by Adin Dental Implants Systems, Ltd.
510(k) K153111
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153111 | Date6 May 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DZE
- FDA applicant
- Adin Dental Implants Systems , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Touareg CloseFit UNP 2.75mmD is a tapered dental implant classified under the Dental Implant, Endosseous, Single-Tooth Replacement category. It features an ultra-narrow platform diameter of 2.75mm and a conical-hex connection designed to minimize micromovements between the implant and abutment, reducing potential bone resorption. The implant incorporates an OsseoFix™ titanium surface treatment, which uses calcium phosphate gritting to achieve optimal roughness for enhanced osseointegration. Its biocompatible design supports stable integration with surrounding bone tissue.
This dental implant is supplied as a single-use, sterile device intended for surgical placement in the jawbone to support a single dental crown or prosthetic tooth. The conical-hex connection ensures a secure fit, reducing the risk of loosening over time. The device is available in a tapered design with a 2.75mm diameter and is regulated under FDA 510(k) clearance (K153111) as substantially equivalent to a predicate device. Storage should follow manufacturer guidelines to maintain sterility and integrity prior to use.
Other devices from Adin Dental Implants Systems, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Touareg CloseFit UNP 2.75mmD dental implant designed for?
The Touareg CloseFit UNP 2.75mmD is a tapered dental implant specifically designed for single-tooth replacement in the jawbone. Its ultra-narrow platform diameter of 2.75mm and conical-hex connection are engineered to minimize micromovements between the implant and abutment, thereby reducing the risk of bone resorption and promoting stable integration with surrounding bone tissue. This design supports the placement of a single dental crown or prosthetic tooth.
How is the Touareg CloseFit UNP 2.75mmD supplied and what does this mean for clinical use?
The Touareg CloseFit UNP 2.75mmD is supplied as a single-use, sterile device. This means each implant is intended for one surgical procedure only and must remain unopened until use. Sterility is critical for preventing infection, so adhering to the manufacturer’s storage guidelines ensures the device remains intact and uncontaminated prior to implantation. Clinicians should follow aseptic techniques during handling and placement.
What surface treatment does the Touareg CloseFit UNP 2.75mmD use, and why is it important?
The implant features an OsseoFix™ titanium surface treatment, which incorporates calcium phosphate gritting to create an optimal roughness. This enhances osseointegration—the process where bone tissue grows directly into the implant surface—by providing a more favorable environment for bone cells to adhere and proliferate. Improved osseointegration leads to stronger, more stable implant integration over time.
Is the Touareg CloseFit UNP 2.75mmD reusable, or is it intended for single-use only?
The Touareg CloseFit UNP 2.75mmD is explicitly designed for single-use only. This classification ensures sterility and safety for each patient, as reusing implants could compromise integrity and introduce infection risks. Single-use implants also align with best practices in dental surgery to maintain high standards of hygiene and clinical outcomes.
How should the Touareg CloseFit UNP 2.75mmD be stored to maintain its sterility and integrity?
The Touareg CloseFit UNP 2.75mmD must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. Typically, this involves keeping the implant in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoiding contamination and physical damage ensures the device remains ready for safe surgical use when needed.