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

Orthodontic Led Accessory

21 CFR 872.5470 / Dental
FDA source (opens on fda.gov)

PLH is the FDA product code for Orthodontic Led Accessory, a class II device type, regulated under 21 CFR 872.5470. FDA's definition for this code reads: "Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLH
Device name
Orthodontic Led Accessory
FDA definition
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PLH

By decision year
2 clearances under product code PLH with a decision year between 2015 and 2023, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLH by decision year
YearClearances
20151
20231

Applicants with the most clearances

Product code PLH
Applicants holding the most 510(k) clearances under product code PLH
ApplicantClearances
Biolux Research, Ltd.1
Biolux Technology GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code