Cleared Traditional

Porcine Mineral Collagen Composite

K202183 · Collagen Matrix, Inc. · Dental

Apr 2021

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K202183 is an FDA 510(k) clearance for the Porcine Mineral Collagen Composite, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on April 2, 2021, 241 days after receiving the submission on August 4, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K202183 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2020
Decision Date	April 02, 2021
Days to Decision	241 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.