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510(k) K903672

DENE BRIDGE by Dirotian Pty. , Ltd. — Product Code EKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1990
Date Received
August 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture Preformed (Partially Prefabricated Denture)
Device Class
Class II
Regulation Number
872.3600
Review Panel
DE
Submission Type

Other clearances for product code EKO

  • K892255 — DENTAL ROOT ELEVATOR (May 1, 1989)
  • K780722 — ADVANCED DENTURE SYSTEM (May 26, 1978)
  • K760768 — FLEXIDENT DENTURE (October 15, 1976)