EHA — Aligner, Beam, X-Ray Class I

FDA Device Classification

FDA product code EHA covers "Aligner, Beam, X-Ray", a Class I medical device regulated under 21 CFR 872.1820. 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
EHA
Device Class
Class I
Regulation Number
872.1820
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K891186benn researchREPOSITIONABLE BITEWING X-RAY FILM HOLDER KITApril 12, 1989