510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EJFClass I

Bracket, Metal, Orthodontic

21 CFR 872.5410 / Dental
FDA source (opens on fda.gov)

EJF is the FDA product code for Bracket, Metal, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 103 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
EJF
Device name
Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
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
103
Ingested recalls
8

Clearances, product code EJF

By decision year
103 clearances under product code EJF with a decision year between 1977 and 2000, 1989 the highest year at 25.
Show the numbers
510(k) clearances under FDA product code EJF by decision year
YearClearances
19771
19781
19801
19812
19843
19852
19873
19887
198925
199022
19917
19926
199310
199412
20001

Applicants with the most clearances

Product code EJF
Applicants holding the most 510(k) clearances under product code EJF
ApplicantClearances
American Orthodontics22
Ormco Corp.8
Flexmedics7
Lancer Orthodontics, Inc.7
Gac Intl., Inc.5
Masel Industries, Inc.4
Unitek Corp.4
A Company, Inc.2
Acme-Monaco Corp.2
Alexotek Co.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 157 companies shown, in name order