FDA Product Code NPK: Barrier, Synthetic, Intraoral
A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
Leading manufacturers include Criteria Industria E Comercio DE Produtos Medicinais, Purgo Biologics, Inc. and Cowellmedi Co., Ltd..
FDA 510(k) Cleared Barrier, Synthetic, Intraoral Devices (Product Code NPK)
About Product Code NPK - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code NPK since 1986, with 31 receiving FDA clearance (average review time: 240 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
NPK devices are reviewed by the Dental panel. Browse all Dental devices →