Elos Accurate Denture Fixation System
510(k) K253774
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253774 | Date20 May 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Elos Accurate Denture Fixation System is a dental device classified as a denture fixation system, designed to secure removable overdentures for patients with partial or complete edentulism. It comprises a titanium alloy (Ti-6Al-4V ELI) denture abutment with a TiCN coating, a titanium alloy denture cap, and a flexible polyamide 12 retaining ring, ensuring stable retention of prosthetic appliances.
This system is intended for use in clinical dental settings and is supplied as a reusable or single-use device (sterility status not specified in data). The titanium components are MRI-safe, and the system is available in standardized configurations as defined by the manufacturer. It holds FDA 510(k) clearance (K253774) under product code NHA, with a decision date of May 20, 2026, and is regulated as a Class 2 dental device.
From the manufacturer
Elos Medtech is your trusted partner for product development and manufacturing solutions.
Other devices from Elos Medtech Pinol A/S
Questions
AI-generated answers, 18 Sep 2026
What types of patients is the Elos Accurate Denture Fixation System designed to help secure their dentures?
The Elos Accurate Denture Fixation System is specifically designed for patients with partial or complete edentulism, meaning those who have lost some or all of their natural teeth and rely on removable overdentures for restoration. It provides stable retention to improve the fit and security of these prosthetic appliances.
Is the Elos Accurate Denture Fixation System safe to use in an MRI environment, and what materials are used in its construction?
Yes, the titanium components of the Elos Accurate Denture Fixation System are MRI-safe, making it suitable for patients who may require MRI scans. The system includes a titanium alloy (Ti-6Al-4V ELI) denture abutment with a TiCN coating and a titanium alloy denture cap, ensuring compatibility with MRI procedures while maintaining durability.
How is the Elos Accurate Denture Fixation System supplied, and can it be reused?
The Elos Accurate Denture Fixation System is supplied as either a reusable or single-use device, though the specific sterility status for reuse is not detailed in the provided data. Clinicians should follow manufacturer guidelines for sterilization and reuse protocols to ensure patient safety and device integrity.
What regulatory pathway did the Elos Accurate Denture Fixation System follow to gain clearance, and what class does it fall under?
The Elos Accurate Denture Fixation System received FDA clearance through a traditional 510(k) pathway, specifically under product code NHA, and is classified as a Class 2 dental device. The clearance decision was based on a determination of substantial equivalence to a predicate device, with a decision date of May 20, 2026.