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510(k) K152023

Luminesse Shaded Zirconia SZ by Talladium, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
July 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

Other clearances by Talladium, Inc.

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  • K142371 — Luminesse PMMA (April 24, 2015)
  • K140848 — LUMINESSE PORCELAIN SYSTEM (December 17, 2014)
  • K100232 — LUMINESSE ZR BLANKS (May 21, 2010)
  • K894085 — TALLADIUM TILITE CERAMIC ALLOY (December 20, 1989)

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