Cleared Traditional

OpenTex

K222549 · Purgo Biologics, Inc. · Dental

May 2023

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K222549 is an FDA 510(k) clearance for the OpenTex, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on May 11, 2023, 261 days after receiving the submission on August 23, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K222549 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2022
Decision Date	May 11, 2023
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	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.