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Pacific 56 (CB-40)

by Gateway Alloys, Inc.

510(k) K964837

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 NumberK964837 Date20 Dec 1996ClearedStatusActive

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  • Withdrawn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
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Pacific 56 (CB-40) is a gold-based noble metal alloy device classified under the dental specialty. It is identified by the product code EJT and regulation number 872.3060, and was determined to be substantially equivalent through a traditional 510(k) clearance pathway.

The device was manufactured by Gateway Alloys, Inc. and received FDA 510(k) clearance under K964837 on December 20, 1996. It is supplied as a non-sterile, reusable dental alloy material intended for use in dental applications, with no indication of MRI safety or single-use designation in the provided data.

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Questions

AI-generated answers, 26 Sep 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 Pacific 56 (CB-40) used for?

    The Pacific 56 (CB-40) is a gold-based noble metal alloy device intended for use in dental applications, as indicated by its classification under the dental specialty and product code EJT, which corresponds to gold-based noble metal alloys for dental restorations.

  • Is the Pacific 56 (CB-40) sterile or single-use?

    The device is supplied as non-sterile and reusable, with no indication of single-use designation in the provided data, meaning it is intended for multiple uses after appropriate cleaning and sterilization by the user.

  • How was the Pacific 56 (CB-40) cleared for market?

    The Pacific 56 (CB-40) received FDA 510(k) clearance under K964837 on December 20, 1996, through a traditional clearance pathway, and was determined to be substantially equivalent to a predicate device.

  • What regulatory identifiers are associated with the Pacific 56 (CB-40)?

    The device is identified by product code EJT, regulation number 872.3060, and FDA 510(k) number K964837, and is classified as a Class II device under the dental specialty with FEI number 3009300369 and other associated registration numbers.