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510(k) K213722

ICE Ceramics, ICE Stains, Fresco by Zirkonzahn Srl — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2022
Date Received
November 26, 2021
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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  • K190518 — Color Liquid, Vita Liquid (November 22, 2019)
  • K183304 — Prettau, ICE, Z-White zirconia blanks (April 4, 2019)
  • K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON (June 28, 2018)
  • K181484 — Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissu (June 18, 2018)
  • K151490 — PRETTAU ANTERIOR T0 (October 8, 2015)
  • K132230 — ICE ZIRKON TRANSLUZENT (November 5, 2014)
  • K061851 — ZIRKONZAHN ICE (September 29, 2006)

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