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510(k) K142043

INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA by Jensen Industries, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
July 28, 2014
Clearance Type
Abbreviated
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 Jensen Industries, Inc.

  • K183408 — Jensen Shade Effect Liquids (March 20, 2019)
  • K112806 — JENSEN ZIRCONIA (December 1, 2011)
  • K111743 — THE INSYNC CERAMIC SYSTEM (September 14, 2011)
  • K070114 — CREATION CP-ZI PORCELAIN (March 1, 2007)
  • K050838 — THE LF-P CERAMIC SYSTEM (May 4, 2005)
  • K043201 — WILLI GELLER CREATION ZI PORCELAIN (January 11, 2005)
  • K043221 — WILLI GELLER CREATION CP PORCELAIN (December 20, 2004)
  • K032267 — R&D DESIGNATION AP-052-5 (September 17, 2003)
  • K022206 — JENSEN GOLD FOIL (August 29, 2002)
  • K010414 — R & D DESIGNATION AP-035 (March 27, 2001)

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