Skip to content

PRINCE

by Goldsmith & Revere, Inc.

510(k) K933309

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 NumberK933309 Date1 Oct 1993ClearedStatusActive

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  • Withdrawn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, 22 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 PRINCE is a dental device classified as an Alloy, Amalgam under product code EJJ. It is a Class II device that has been determined to be substantially equivalent to other marketed devices.

The PRINCE is manufactured by Goldsmith & Revere, Inc. and received FDA 510(k) clearance on October 1, 1993. The device is supplied in various sizes as indicated by the multiple registration numbers associated with it. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the device data.

Other devices from Goldsmith & Revere, Inc.

Questions

AI-generated answers, 22 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 PRINCE dental device used for?

    The PRINCE is a dental device classified as an Alloy, Amalgam under product code EJJ. It is a Class II device that has been determined to be substantially equivalent to other marketed devices for dental applications.

  • What sizes and models of PRINCE are available?

    The PRINCE is supplied in various sizes as indicated by the multiple registration numbers associated with it. The specific sizes and models are detailed in the registration numbers provided in the device data.

  • What is the regulatory status of the PRINCE device?

    The PRINCE device received FDA 510(k) clearance on October 1, 1993, and has been determined to be substantially equivalent to other marketed devices. It is classified as a Class II device under product code EJJ.

  • Is the PRINCE device sterile or single-use?

    No information regarding sterility, single-use or reusable status is provided in the device data. The manufacturer should be consulted for specific details on handling and usage instructions.