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 Research , Ltd. and 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
Cleared
Jun 09, 2023
OrthoPulse 2.0E (OPi2E-100)
Biolux Technology GmbH
Dental
70d
Cleared
Jul 24, 2015
OrthoPulse
Biolux Research , Ltd.
Dental
267d
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.