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510(k) K151142

IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID by Wieland Dental + Technik GmbH & Co. KG — Product Code EBI

K151142 is an FDA 510(k) premarket notification submitted by Wieland Dental + Technik GmbH & Co. KG for the device "IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID". The FDA issued a decision of Substantially Equivalent on August 13, 2015. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Wieland Dental + Technik GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2015
Date Received
April 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Wieland Dental + Technik GmbH & Co. KG

  • K152118 — Zenostar MT, Zenostar Color Liquids (December 16, 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)
  • 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)

Other clearances for product code EBI

  • K262300 — Denture Base Resin V2 (July 8, 2026)
  • K261474 — DENTCA Tru Flexible (July 1, 2026)
  • K260569 — DB 4000 High Impact Denture Base (June 2, 2026)
  • K260376 — Denture Base (May 6, 2026)
  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)

FDA data resources