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

Clasp, Wire

21 CFR 872.3285 / Dental
FDA source (opens on fda.gov)

EJW is the FDA product code for Clasp, Wire, a class I device type, regulated under 21 CFR 872.3285. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EJW
Device name
Clasp, Wire
Regulation
21 CFR 872.3285
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
3
Ingested recalls
0

Clearances, product code EJW

By decision year
3 clearances under product code EJW with a decision year between 1987 and 1990, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EJW by decision year
YearClearances
19871
19881
19901

Applicants with the most clearances

Product code EJW
Applicants holding the most 510(k) clearances under product code EJW
ApplicantClearances
Austenal Dental, Inc.1
Flexmedics1
Ivoclar North America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code