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510(k) K993717

ENIGMA HI-BASE DENTURE BASE MATERIAL by Davis Schottlander & Davis, Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1999
Date Received
November 3, 1999
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.

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  • K024250 — MATCH PRESS PRESSABLE CERAMIC (August 25, 2003)
  • K001463 — SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 (June 16, 2000)
  • 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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