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Primallor 1

by Degussa Corp. 510(k)

Active United States

510(k) K951784

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951784 Date6 Jun 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 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.

Primallor 1 is a gold-based noble metal alloy used in dental applications. It is classified as a class 2 dental device.

This device is subject to FDA 510(k) clearance under regulation number 872.3060. It was determined to be substantially equivalent to existing devices through a traditional clearance process.

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