MDL — Implant, Transmandibular Class II

FDA Device Classification

FDA product code MDL covers "Implant, Transmandibular", a Class II medical device regulated under 21 CFR 872.4760. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MDL
Device Class
Class II
Regulation Number
872.4760
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K900433interphase implantsSMOOTH STAPLE IMPLANTNovember 16, 1990
K852894ormcoORMCO TRANSMANDIBULAR IMPLANTAugust 29, 1985