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510(k) K013674

LUXATEMP/LUXATEMP SOLAR/INSTATEMP by Dmg USA, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
November 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Dmg USA, Inc.

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  • K110759 — TEMPOCEM (June 10, 2011)
  • K102603 — SA FLOWABLE ADHESIVE (November 17, 2010)
  • K101710 — LUXATEMP ULTRA /STAR (September 28, 2010)
  • K100062 — INFILTRATION KIT (March 26, 2010)
  • K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT (February 12, 2010)
  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)

Other clearances for product code EBG

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  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
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  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)