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Luxatemp/Luxatemp Solar/Instatemp

by Dmg USA, Inc. 510(k)

Active United States

510(k) K013674

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013674 Date24 Jan 2002ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

LUXATEMP/LUXATEMP SOLAR/INSTATEMP is a dual-cure provisional crown and bridge composite. It is used for temporary crowns and bridges, long-term temporaries, inlays and onlays, and for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

The device is supplied by Dmg USA, Inc. and has received FDA 510(k) clearance under K013674 with product code EBG. It is classified as a Class II device in the Dental specialty under regulation 872.3770, with a traditional clearance type and decision date of 2002-01-24.

Other devices from Dmg USA, Inc.

See all devices from Dmg USA, Inc. →

Questions

AI-generated answers, 19 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 LUXATEMP/LUXATEMP SOLAR/INSTATEMP device used for?

    The device is a dual-cure provisional crown and bridge composite used for temporary crowns and bridges, long-term temporaries, inlays and onlays, and for incorporating mechanically anchored attachment components into the acrylic base of dentures, overdentures, or partial dentures.

  • How is the LUXATEMP/LUXATEMP SOLAR/INSTATEMP supplied and by whom?

    The device is supplied by Dmg USA, Inc., located at 5 Whitcomb Ave., Ayer, MA 01432, as indicated in the manufacturer and address details provided in the device data.

  • What regulatory pathway was used for the LUXATEMP/LUXATEMP SOLAR/INSTATEMP device?

    The device received FDA 510(k) clearance under K013674, which is a traditional clearance type, as stated in the authorizations and specifications sections of the device data.

  • What is the product code and classification for the LUXATEMP/LUXATEMP SOLAR/INSTATEMP device?

    The device has product code EBG and is classified as a Class II device in the Dental specialty under regulation 872.3770, based on the specifications provided in the device data.

  • When was the LUXATEMP/LUXATEMP SOLAR/INSTATEMP device cleared by the FDA?

    The device received FDA clearance on January 24, 2002, as indicated by the decision date in the specifications section of the device data.