ECR · Class I · 21 CFR 872.4565

FDA Product Code ECR: Setter, Band, Orthodontic

Leading manufacturers include Essential Dental Systems, Inc., 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

Cleared Feb 03, 1994

DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS

Dentauraum, Inc.

Cleared Sep 27, 1984

Essential Dental Systems, Inc.

About Product Code ECR - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 176,325 total devices indexed.

Latest clearance: May 23, 1995

Product Code Info

Code	ECR
Device class	Class I
CFR	21 CFR 872.4565
Panel	Dental

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