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510(k) K080182

ZENO PMMA DISC by Wieland Dental + Technik GmbH & Co. KG — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2008
Date Received
January 25, 2008
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

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  • K142233 — zenostar MO, Zenostar T, Zenostar VisualiZr (January 5, 2015)
  • 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)
  • K073108 — ZENO ZR DISC (November 21, 2007)
  • K070772 — PRESSX ZR (April 30, 2007)

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