Cleared Traditional

The Graft Bone Substitute

K191737 · Purgo Biologics, Inc. · Dental
Feb 2020
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K191737 is an FDA 510(k) clearance for the The Graft 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 February 14, 2020, 231 days after receiving the submission on June 28, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K191737 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2019
Decision Date February 14, 2020
Days to Decision 231 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.