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Device Classification
/ EKA
EKA — File, Margin Finishing, Operative
Class I
FDA Device Classification
Classification Details
Product Code
EKA
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K830764
shizai
FR ROOT CANAL SEALER
July 26, 1983
K822464
u.s. shizai
OBTURATION GUTTA
November 3, 1982