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510(k) K003509

FLEXICAST by American Dent-All, Inc. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2001
Date Received
November 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by American Dent-All, Inc.

  • K030161 — SUPERBOND (March 17, 2003)
  • K011706 — FLEXICAST PRIME (August 6, 2001)
  • K011705 — SUPREMCAST (August 3, 2001)
  • K001383 — SUPREMCAST V (July 5, 2000)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)