Identifiers
- 510(k) Number
- K972532 FDA 510(k)
- FDA Product Code
- EJT 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)
The Aalba Gold Solder is a gold-based noble metal alloy designed for dental soldering. It serves as a metallic joining material used in the construction and repair of crown and bridge dental prosthetics, ensuring durable and precise connections between dental restorations.
This solder is supplied as a dental laboratory material and is intended for use in conjunction with Aalba Flux. It is classified as a Class II medical device under FDA regulations (21 CFR 872.3060) and has received FDA 510(k) clearance (K972532) as substantially equivalent to a predicate device. The product is non-sterile and reusable for dental laboratory applications.
Frequently asked questions
What is the Aalba Gold Solder used for in dental applications?
The Aalba Gold Solder is specifically designed for dental soldering, serving as a metallic joining material in the construction and repair of crown and bridge dental prosthetics. It ensures durable and precise connections between dental restorations, helping to maintain the structural integrity of restorative work in the dental laboratory.
Is the Aalba Gold Solder sterile and intended for direct patient use?
No, the Aalba Gold Solder is explicitly labeled as non-sterile and is intended only for dental laboratory applications. It is not meant for direct patient use or clinical procedures involving the mouth. Its use is restricted to joining components in a controlled lab environment before final placement in a patient.
How is the Aalba Gold Solder supplied, and what materials are required for its use?
The Aalba Gold Solder is supplied as a dental laboratory material and must be used in conjunction with Aalba Flux to ensure proper soldering. It is designed for reuse within the dental lab setting, meaning it is not a single-use product but rather intended for repeated applications in a controlled environment.
What regulatory pathway was followed for FDA clearance of the Aalba Gold Solder?
The Aalba Gold Solder received FDA 510(k) clearance (K972532) under the traditional review pathway, with a decision date of August 15, 1997. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device under 21 CFR 872.3060, reflecting its dental specialty designation and intended use in laboratory settings.
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: Aalba Gold Solder | Aalbadent, Aalbadent | Base Metal Restorative Alloys, Aalba Dent - Aalba Dent Catalog - English, AALBA GOLD SOLDER (K972532) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972532 | Class II | Active |
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Manufacturer
- Manufacturer
- Aalba Dent, Inc.
Sources (1)
- FDA 510(k) K972532 24 fields · synced Sep 19, 2026