Cleared Abbreviated

The Graft Natural Bone Substitute

K173188 · Purgo Biologics, Inc. · Dental

Jul 2018

Decision

291d

Days

Class 2

Risk

About This 510(k) Submission

K173188 is an FDA 510(k) clearance for the The Graft Natural Bone Substitute, 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 20, 2018, 291 days after receiving the submission on October 2, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K173188 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2017
Decision Date	July 20, 2018
Days to Decision	291 days
Submission Type	Abbreviated
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.