ECSClass I

Pusher, Band, Orthodontic

21 CFR 872.4565 / Dental

ECS is the FDA product code for Pusher, Band, Orthodontic, a class I device type, regulated under 21 CFR 872.4565. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1994-02-04, and no recalls.

Classification record

Product code: ECS
Device name: Pusher, Band, Orthodontic
Regulation: 21 CFR 872.4565
Device class: Class I
Review panel: Dental
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code ECS

By decision year

2 clearances under product code ECS with a decision year between 1992 and 1994, 1992 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ECS by decision year
Year	Clearances
1992	1
1994	1

Applicants with the most clearances

Product code ECS

Applicants holding the most 510(k) clearances under product code ECS
Applicant	Clearances
Dentauraum, Inc.	1
Glenroe Technologies	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 102 companies shown, in name order

Recent clearances

Product code ECS

Recent recalls

Product code ECS

FDA records show no recalls under product code ECS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)