FDA Product Code PLV: Dental Stereotaxic Instrument
To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.
Leading manufacturers include Neocis, Inc., Claronav, Inc. and Navigate Surgical Technologies, Inc..
FDA 510(k) Cleared Dental Stereotaxic Instrument Devices (Product Code PLV)
About Product Code PLV - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code PLV since 2015, with 23 receiving FDA clearance (average review time: 156 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
FDA review times for PLV submissions have been consistent, averaging 156 days recently vs 156 days historically.
PLV devices are reviewed by the Dental panel. Browse all Dental devices →