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510(k) K061851

ZIRKONZAHN ICE by Zirkonzahn GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2006
Date Received
June 30, 2006
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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  • 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)

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