DYT — Maintainer, Space Preformed, Orthodontic Class I

FDA Device Classification

FDA product code DYT covers "Maintainer, Space Preformed, Orthodontic", a Class I medical device regulated under 21 CFR 872.5525. Submissions are reviewed by the Dental panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DYT
Device Class
Class I
Regulation Number
872.5525
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935856dentauraumDENTAURUM SPACE MAINTAINERApril 28, 1994
K864376dentecFIBERBONDApril 7, 1987
K812239unitekUNITEK PALATAL BARSeptember 21, 1981
K780814northwest orthodonticsSAFETY STOP NECKSTRAPJune 30, 1978