Cleared Traditional

Porcine Mineral Collagen Composite Moldable

K201859 · Collagen Matrix, Inc. · Dental
Sep 2020
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K201859 is an FDA 510(k) clearance for the Porcine Mineral Collagen Composite Moldable, 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 September 11, 2020, 67 days after receiving the submission on July 6, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K201859 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2020
Decision Date September 11, 2020
Days to Decision 67 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.