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510(k) K152118

Zenostar MT, Zenostar Color Liquids by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2015
Date Received
July 30, 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

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  • K130184 — ZENOLUX (May 24, 2013)
  • K112710 — ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR (October 17, 2011)
  • K103773 — ZENOFLEX DIMENSION (March 16, 2011)
  • K103494 — ZENOSTAR MAGIC GLAZE (February 16, 2011)
  • K082257 — ZENO AI ECO DISC (September 18, 2008)
  • K080182 — ZENO PMMA DISC (April 8, 2008)
  • K073108 — ZENO ZR DISC (November 21, 2007)
  • K070772 — PRESSX ZR (April 30, 2007)

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