Home / 510(k) Clearances / K830764

510(k) K830764

FR ROOT CANAL SEALER by Shizai Corp. — Product Code EKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
March 10, 1983
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 Shizai Corp.

  • K830763 — FR ROOT CANAL FILLER (August 26, 1983)

Other clearances for product code EKA

  • K822464 — OBTURATION GUTTA (November 3, 1982)