KCR — Facebow Class I

FDA Device Classification

FDA product code KCR covers "Facebow", a Class I medical device regulated under 21 CFR 872.3220. 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
KCR
Device Class
Class I
Regulation Number
872.3220
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K830775almore intlFACEBOW FOR BALANCE ARTICULATORApril 28, 1983