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510(k) K822464

OBTURATION GUTTA by U.S. Shizai Corp. — Product Code EKA

K822464 is an FDA 510(k) premarket notification submitted by U.S. Shizai Corp. for the device "OBTURATION GUTTA". The FDA issued a decision of Substantially Equivalent on November 3, 1982. The device falls under product code EKA (File, Margin Finishing, Operative), a Class I device regulated under 21 CFR 872.4565. U.S. Shizai Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1982
Date Received
August 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Margin Finishing, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by U.S. Shizai Corp.

  • K853841 — HARMO SONIC (February 4, 1986)
  • K820639 — OBTURATION SYSTEM KIT (April 9, 1982)
  • K802189 — DENTLOID (September 26, 1980)
  • K800951 — CASTA-LLOY (May 8, 1980)

Other clearances for product code EKA

  • K830764 — FR ROOT CANAL SEALER (July 26, 1983)

FDA data resources