FDA Product Code PLH: Orthodontic Led Accessory
Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Brackets And Wires Or Aligners And Helps Facilitate Minor Anterior Tooth Movement.
Leading manufacturers include Biolux Technology GmbH.
2
Total
2
Cleared
169d
Avg days
2015
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Orthodontic Led Accessory Devices (Product Code PLH)
2 devices
About Product Code PLH - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PLH since 2015, with 2 receiving FDA clearance (average review time: 169 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PLH devices are reviewed by the Dental panel. Browse all Dental devices →