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510(k) K800951

CASTA-LLOY by U.S. Shizai Corp. — Product Code EJS

K800951 is an FDA 510(k) premarket notification submitted by U.S. Shizai Corp. for the device "CASTA-LLOY". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. U.S. Shizai Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by U.S. Shizai Corp.

  • K853841 — HARMO SONIC (February 4, 1986)
  • K822464 — OBTURATION GUTTA (November 3, 1982)
  • K820639 — OBTURATION SYSTEM KIT (April 9, 1982)
  • K802189 — DENTLOID (September 26, 1980)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources