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Luxaform

by Dmg USA, Inc. 510(k)

Active United States

510(k) K000951

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000951 Date5 Apr 2000ClearedStatusActive

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  • Withdrawn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
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Luxaform is a thermoplastic impression polymer designed for use in the dental field. It functions as a material for creating dental impressions.

This device is a Class 2 dental product cleared through the FDA 510(k) traditional pathway. It is identified by product code EBG and is manufactured by Dmg USA, Inc.

Other devices from Dmg USA, Inc.

See all devices from Dmg USA, Inc. →

Questions

AI-generated answers, 25 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 primary clinical use of Luxaform?

    Luxaform is a thermoplastic polymer specifically designed for the dental field. Its primary function is to serve as a material for creating dental impressions during clinical procedures.

  • Who is the manufacturer of the Luxaform impression material?

    Luxaform is manufactured by Dmg USA, Inc., which is located in Ayer, Massachusetts.

  • What is the regulatory status of Luxaform?

    Luxaform is a Class 2 dental product that has been cleared through the FDA 510(k) traditional pathway, identified by the K-number K000951 and product code EBG.