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510(k) K953594

VULCAN by Cmp Industries, LLC — Product Code EJH

K953594 is an FDA 510(k) premarket notification submitted by Cmp Industries, LLC for the device "VULCAN". The FDA issued a decision of Substantially Equivalent on September 5, 1995. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Cmp Industries, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1995
Date Received
July 31, 1995
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 Cmp Industries, LLC

  • K170423 — DentureID Microchip (October 25, 2017)
  • K170375 — Nobilplast Denture Resin (October 2, 2017)
  • K072851 — POLYSTAR 79 DENTURE BASE RESIN (February 20, 2008)
  • K072402 — FLEX-STAR V (October 19, 2007)
  • K033020 — IMPAK ACRYLIC REPAIR RESIN LIQUID (December 19, 2003)
  • K902972 — FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) (October 4, 1990)

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)

FDA data resources