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510(k) K984128

ENIGMA DENTURE TEETH by Davis Schottlander & Davis, Ltd. — Product Code ELM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1999
Date Received
November 18, 1998
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 Davis Schottlander & Davis, Ltd.

  • K024252 — MATCH MASTER LOW FUSION PORCELAIN (January 22, 2004)
  • K024250 — MATCH PRESS PRESSABLE CERAMIC (August 25, 2003)
  • K001463 — SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 (June 16, 2000)
  • K993717 — ENIGMA HI-BASE DENTURE BASE MATERIAL (December 22, 1999)
  • K984134 — NATURA DENTURE TEETH (February 12, 1999)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)

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)