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ECR — Setter, Band, Orthodontic Class I

FDA Device Classification

FDA product code ECR covers "Setter, Band, Orthodontic", a Class I medical device regulated under 21 CFR 872.4565. 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
ECR
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951776ormcoBAND SEATERMay 23, 1995
K935156dentauraumDENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTSFebruary 3, 1994
K843018essential dental systemsFLEXI-POSTSeptember 27, 1984

FDA data resources