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DYO — Band, Material, Orthodontic Class I

FDA Device Classification

FDA product code DYO covers "Band, Material, Orthodontic", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DYO
Device Class
Class I
Regulation Number
872.5410
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935152dentauraumDENTAURUM DENTAFORM BANDS, DENTAURUM STANDARDJanuary 31, 1994
K931980ortho organizersSTAINLESS STEEL ORTHODONTIC PRODUCTSSeptember 1, 1993
K844034echo ultrasoundSONOCAREJanuary 23, 1985

FDA data resources