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510(k) K001463

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 by Davis Schottlander & Davis, Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2000
Date Received
May 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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)
  • K993717 — ENIGMA HI-BASE DENTURE BASE MATERIAL (December 22, 1999)
  • K984134 — NATURA DENTURE TEETH (February 12, 1999)
  • K984128 — ENIGMA DENTURE TEETH (February 9, 1999)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)

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