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Elos Accurate Hybrid Base; Elos Accurate Customized Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241722

by Elos Medtech Pinol A/S

Identifiers

510(k) Number
K241722 FDA 510(k)
FDA Product Code
NHA FDA 510(k)
Models / Variants
Elos Accurate® Hybrid Base™ FDA 510(k)
Elos Accurate® Customized Abutment FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elos Accurate Hybrid Base and Customized Abutment are dental components designed for use in implant-supported restorations. These devices serve as interfaces between dental implants and prosthetic superstructures, facilitating secure and anatomically adapted connections in fixed prosthodontics. The Hybrid Base incorporates titanium for stability, while the Customized Abutment is tailored to optimize soft tissue integration and crown fit.

These components are supplied non-sterile and require sterilization prior to patient use. They are intended for single-patient application in dental offices or clinics, adhering to standard dental implant protocols. The devices are classified under the FDA’s dental product code (NHA) and were cleared via a 510(k) submission (K241722) as substantially equivalent to predicate devices. No MRI safety information or reusable specifications are provided.

Frequently asked questions

Are these components reusable between patients, or are they meant for single-use only?

The Elos Accurate® Hybrid Base and Customized Abutment are explicitly intended for single-patient application in dental offices or clinics. They are supplied non-sterile and must be sterilized before use with each patient, following standard dental implant protocols. There is no indication or specification provided that these components are designed for reuse.

How should I prepare these devices for patient use, given they are non-sterile?

Since the Elos Accurate® Hybrid Base and Customized Abutment are supplied non-sterile, they require sterilization prior to use with any patient. The manufacturer does not specify a particular sterilization method, so you should follow standard dental sterilization protocols (e.g., autoclave, chemical sterilization) that ensure compatibility with titanium components. Always verify the sterilization process aligns with your clinic’s infection control guidelines.

What are the key differences between the Hybrid Base and the Customized Abutment in terms of their purpose?

The Hybrid Base is designed primarily for stability and secure connection between dental implants and prosthetic superstructures, utilizing titanium for durability. In contrast, the Customized Abutment is tailored to enhance soft tissue integration and crown fit, ensuring a more anatomically adapted interface for the final restoration. Both serve as critical interfaces in fixed prosthodontics but address distinct functional needs.

Are there specific storage instructions for these components, or can they be kept under standard dental office conditions?

The provided data does not specify detailed storage instructions, but since these are non-sterile titanium components, they should be stored in a clean, dry environment protected from moisture, dust, or contamination. Avoid exposure to extreme temperatures or direct sunlight. If sterilized in advance, follow the manufacturer’s guidelines for storing sterilized items to maintain sterility until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DSF - Hybrid Bases - Elos Medtech, PDF Elos Accurate® Hybrid BaseTM - Elos Medtech, Home - Elos Medtech, Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elos Medtech Pinol A/S

Sources (1)

  • FDA 510(k) K241722 24 fields · synced Sep 19, 2026