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

Band, Preformed, Orthodontic

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

ECM is the FDA product code for Band, Preformed, Orthodontic, a class I device type, regulated under 21 CFR 872.5410. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ECM
Device name
Band, Preformed, 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
2
Ingested recalls
0

Clearances, product code ECM

By decision year
2 clearances under product code ECM with a decision year between 1987 and 1993, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ECM by decision year
YearClearances
19871
19931

Applicants with the most clearances

Product code ECM
Applicants holding the most 510(k) clearances under product code ECM
ApplicantClearances
Titane SL Co.1
Unicep1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 85 companies shown, in name order