EML — Chisel, Bone, Surgical Class I

FDA Device Classification

FDA product code EML covers "Chisel, Bone, Surgical", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EML
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K851715artiberia830/4 TO 848/7 VARIOUS TYPES CHISELSJune 11, 1985
K823320miltexDENTAL INSTRUMENTS - BONE CHISELSNovember 24, 1982