ECR · Class I · 21 CFR 872.4565

FDA Product Code ECR: Setter, Band, Orthodontic

Leading manufacturers include Dentauraum, Inc. and Ormco Corp..

3
Total
3
Cleared
65d
Avg days
1984
Since

FDA 510(k) Cleared Setter, Band, Orthodontic Devices (Product Code ECR)

3 devices
1–3 of 3
Cleared May 23, 1995
BAND SEATER
K951776
Ormco Corp.
Dental · 40d
Cleared Feb 03, 1994
DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS
K935156
Dentauraum, Inc.
Dental · 98d

About Product Code ECR - Regulatory Context