Cleared Traditional

THE Graft Collagen

K230305 · Purgo Biologics, Inc. · Dental

Jul 2024

Decision

537d

Days

Class 2

Risk

About This 510(k) Submission

K230305 is an FDA 510(k) clearance for the THE Graft Collagen, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 24, 2024, 537 days after receiving the submission on February 3, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K230305 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2023
Decision Date	July 24, 2024
Days to Decision	537 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPM — Bone Grafting Material, Animal Source
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.