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Dispersed Phase Alloy

by Goldsmith & Revere, Inc.

510(k) K820617

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820617 Date25 Mar 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJJ
Device Class
Class II
Regulation
21 CFR Part 872.3070
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dispersed Phase Alloy is a dental alloy classified under the FDA category of Alloy, Amalgam (Product Code: EJJ). It is designed for dental restorative applications, providing a stable medium for dental fillings and other restorative procedures. This material is intended to offer durability and compatibility within oral environments.

Supplied for reuse in dental practices, the Dispersed Phase Alloy is regulated under FDA 510(k) clearance (K820617) and falls under the classification of Class II medical devices for dental use. It adheres to regulation 872.3070 and is intended for use in dental restorative procedures. Handling and use follow standard dental clinical protocols.

Other devices from Goldsmith & Revere, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dispersed Phase Alloy used for in dental procedures?

    The Dispersed Phase Alloy is designed specifically for dental restorative applications, such as dental fillings. Its formulation provides a stable medium that ensures durability and compatibility within the oral environment, making it suitable for long-term restorations.

  • Is the Dispersed Phase Alloy intended for single-use or reuse in dental practices?

    The Dispersed Phase Alloy is supplied for reuse in dental practices. It is intended to be utilized multiple times following standard dental clinical protocols, ensuring consistent performance for restorative procedures.

  • What regulatory approval does the Dispersed Phase Alloy hold?

    The Dispersed Phase Alloy holds FDA 510(k) clearance (K820617) and is classified as a Class II medical device under regulation 872.3070. This clearance confirms its substantial equivalence to a predicate device, ensuring it meets established safety and effectiveness standards for dental use.

  • How is the sterility of the Dispersed Phase Alloy maintained for reuse?

    While the provided data does not specify explicit sterility protocols, the alloy is intended for reuse in dental practices. Standard clinical protocols for dental materials, including proper cleaning, sterilization, and handling, should be followed to maintain sterility and prevent contamination between uses.

  • Are there different sizes or models of the Dispersed Phase Alloy available?

    The data provided includes multiple FEI numbers (e.g., 3010862763, 3013557562), which may correspond to different lot or batch identifiers rather than distinct sizes or models. For specific sizes or models, refer to the manufacturer’s product catalog or technical documentation, as these identifiers are typically used for tracking and regulatory purposes.