EEJ — Guard, Disk Class I

FDA Device Classification

FDA product code EEJ covers "Guard, Disk", a Class I medical device regulated under 21 CFR 872.6010. 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
EEJ
Device Class
Class I
Regulation Number
872.6010
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K854467nortex usaS.T.P.B SOFT TISSUES PROTECTIVES BLADESMarch 12, 1986