EMR — File, Periodontic Class I

FDA Device Classification

FDA product code EMR covers "File, Periodontic", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
EMR
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
K830109north pacific dentalCIMPATMarch 1, 1983