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

Lock, Wire, And Ligature, Intraoral

21 CFR 872.4600 / Dental
FDA source (opens on fda.gov)

DYX is the FDA product code for Lock, Wire, And Ligature, Intraoral, a class II device type, regulated under 21 CFR 872.4600. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DYX
Device name
Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code DYX

By decision year
11 clearances under product code DYX with a decision year between 1982 and 2017, 1993 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DYX by decision year
YearClearances
19821
19861
19911
19932
19992
20032
20061
20171

Applicants with the most clearances

Product code DYX
Applicants holding the most 510(k) clearances under product code DYX
ApplicantClearances
Casey Surgical, LLC1
Doctor'S Research Group, Inc.1
Instrumentations Unltd.1
KLS-Martin L.P.1
Medical Products & Research, Inc.1
Medtronic, Inc.1
Reliance Orthodontic Products, Inc.1
Summit Medical, LLC1
Synthes (USA) Products LLC1
Unisplint Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code