Home / 510(k) Clearances / K082257

510(k) K082257

ZENO AI ECO DISC by Wieland Dental + Technik GmbH & Co. KG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2008
Date Received
August 8, 2008
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 Wieland Dental + Technik GmbH & Co. KG

  • K152118 — Zenostar MT, Zenostar Color Liquids (December 16, 2015)
  • K151142 — IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (August 13, 2015)
  • 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)
  • K080182 — ZENO PMMA DISC (April 8, 2008)
  • K073108 — ZENO ZR DISC (November 21, 2007)
  • K070772 — PRESSX ZR (April 30, 2007)

Other clearances for product code EIH

  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K254283 — BruxZir® Shaded 16 PLUS (January 30, 2026)
  • K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (January 9, 2026)
  • K252789 — Glass Ceramic (December 8, 2025)
  • K252446 — BruxZir® NOW (September 3, 2025)
  • K251593 — DenMat Multilayered Zirconia Disc (August 25, 2025)
  • K250063 — ARENA Star, Galaxy Star (July 10, 2025)
  • K250826 — Multi M Series (June 12, 2025)
  • K251084 — zirkon; structure; LFU shades, stains and glazes (June 5, 2025)
  • K250673 — CERABIEN MiLai (May 29, 2025)