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

Band, Elastic, Orthodontic

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

ECI is the FDA product code for Band, Elastic, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
ECI
Device name
Band, Elastic, 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
25
Ingested recalls
3

Clearances, product code ECI

By decision year
25 clearances under product code ECI with a decision year between 1978 and 1998, 1993 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code ECI by decision year
YearClearances
19781
19811
19855
19881
19937
19943
19954
19971
19982

Applicants with the most clearances

Product code ECI
Applicants holding the most 510(k) clearances under product code ECI
ApplicantClearances
A Company, Inc.5
Glenroe Technologies4
Jon-Ko Products, Inc.4
Unitek Corp.2
American Orthodontics1
Bioseal1
Dentauraum, Inc.1
Gac Intl., Inc.1
Glenroe, LLC1
Hygienic Dental Mfg., Co., the1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order