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510(k) K111743

THE INSYNC CERAMIC SYSTEM by Jensen Industries, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2011
Date Received
June 21, 2011
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.

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  • K142043 — INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA (December 18, 2014)
  • K112806 — JENSEN ZIRCONIA (December 1, 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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