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FDA Product Code

FDA Product Code EKA — Clearance Directory

Device Class
Class I
Assigned Panel
Dental
21 CFR Citation
872.4565

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K830764 FR ROOT CANAL SEALER Shizai Corp. 1983-07-26 Traditional PDF ↗
K822464 OBTURATION GUTTA U.S. Shizai Corp. 1982-11-03 Traditional PDF ↗

Product code EKA · Class I · Dental. Data: openFDA.