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Vera Solder

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972533

by Aalba Dent, Inc.

Identifiers

510(k) Number
K972533 FDA 510(k)
FDA Product Code
EJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3060 FDA 510(k)
Regulation Number
872.3060 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Vera Solder is a dental soldering alloy composed of other noble metals, designed for joining nickel-based casting alloys. It is formulated for high-fusing applications, ensuring strong and durable connections in dental frameworks and copings. The alloy’s boron enhancement improves fluidity, facilitating precise soldering and optimal performance in restorative procedures.

This solder is supplied as a pre-solder material for use in dental laboratories and clinical settings, intended for repair and construction of nickel-based dental frameworks. It is applied via torch or laser welding and is compatible with both PFM (porcelain-fused-to-metal) and non-PFM applications. The product is classified as a Class II medical device under FDA regulations and is authorized via a 510(k) clearance (K972533). Sterility and single-use or reusable status are not specified in the provided data.

Frequently asked questions

What types of dental frameworks can Vera Solder be used to join or repair, and how is it applied in the lab or clinical setting?

Vera Solder is specifically designed for joining nickel-based casting alloys in dental frameworks, making it suitable for both porcelain-fused-to-metal (PFM) and non-PFM applications. It is supplied as a pre-solder material and is applied using either a torch or laser welding method, ensuring strong and durable connections for restorative procedures.

Is Vera Solder intended for single-use or reusable applications, and what is its sterility status?

The provided data does not specify whether Vera Solder is intended for single-use or reusable applications. Additionally, there is no information regarding its sterility status, so this would need to be confirmed directly with Aalba Dent, Inc. before use.

What regulatory pathway was followed for the approval of Vera Solder, and what classification does it hold under FDA regulations?

Vera Solder is classified as a Class II medical device under FDA regulations and was authorized through a traditional 510(k) clearance process, specifically with the clearance number K972533. The device was determined to be substantially equivalent to a predicate product, as indicated by the decision code SESE.

What are the key features of Vera Solder that make it suitable for high-fusing applications in dental soldering?

Vera Solder is formulated with other noble metals and includes boron enhancement, which improves fluidity during the soldering process. This formulation ensures precise application and optimal performance, making it ideal for high-fusing applications in dental frameworks and copings.

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: Vera Solder | Aalbadent, Vera PD Solder - Aalbadent, [Aalba Dent] Vera-Solder - DentMart Dental Supply

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aalba Dent, Inc.

Sources (1)

  • FDA 510(k) K972533 24 fields · synced Sep 20, 2026