NPK · Class II · 21 CFR 872.3930

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 Osteogenics Biomedical, Inc., B&Medi Co., Ltd. and Cowellmedi Co., Ltd..

31
Total
31
Cleared
240d
Avg days
1986
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Barrier, Synthetic, Intraoral Devices (Product Code NPK)

31 devices
1–24 of 31
Cleared Dec 08, 2023
Lumina-PTFE Titanium
K221851
Criteria Industria E Comercio DE Produtos Medicinais
Dental · 529d
Cleared May 11, 2023
OpenTex
K222549
Purgo Biologics, Inc.
Dental · 261d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
K210797
B&Medi Co., Ltd.
Dental · 520d
Cleared Jan 23, 2021
Cytoplast Titanium-Reinforced PTFE Membranes
K201187
Osteogenics Biomedical, Inc.
Dental · 267d
Cleared May 20, 1996
VICRYL PERIDONTAL MESH
K955646
Ethicon, Inc.
Dental · 160d

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.