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510(k) K780722

ADVANCED DENTURE SYSTEM by Advanced Marketing Research Co. — Product Code EKO

K780722 is an FDA 510(k) premarket notification submitted by Advanced Marketing Research Co. for the device "ADVANCED DENTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code EKO (Denture Preformed (Partially Prefabricated Denture)), a Class II device regulated under 21 CFR 872.3600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1978
Date Received
May 1, 1978
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

  • K903672 — DENE BRIDGE (December 5, 1990)
  • K892255 — DENTAL ROOT ELEVATOR (May 1, 1989)
  • K760768 — FLEXIDENT DENTURE (October 15, 1976)

FDA data resources