Cleared Traditional

THE Cover

K230091 · Purgo Biologics, Inc. · Dental

Oct 2023

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K230091 is an FDA 510(k) clearance for the THE Cover, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 6, 2023, 267 days after receiving the submission on January 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K230091 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2023
Decision Date	October 06, 2023
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPL — Barrier, Animal Source, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.