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
510(k) Exempt
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K851715Artiberia830/4 TO 848/7 VARIOUS TYPES CHISELSJun 11, 1985
K823320MiltexDENTAL INSTRUMENTS - BONE CHISELSNov 24, 1982

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.