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510(k) K010160

WILLI GELLER CREAPEARL by Jensen Industries, Inc. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2001
Date Received
January 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
Review Panel
DE
Submission Type

Other clearances by Jensen Industries, Inc.

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  • 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)

Other clearances for product code ELM

  • K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (January 14, 2014)
  • K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (March 1, 2013)
  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
  • K122852 — PHYSIOSTAR NFC (December 6, 2012)
  • K121749 — VERACIA (September 7, 2012)
  • K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (May 21, 2012)
  • K120736 — SR PHONARES II (May 14, 2012)
  • K113426 — VERACIA SA (February 8, 2012)
  • K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (September 14, 2010)
  • K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYM (August 16, 2010)