Cleared Traditional

Anorganic Bone Mineral with Collagen in Delivery Applicator

K171008 · Collagen Matrix, Inc. · Dental
Oct 2017
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K171008 is an FDA 510(k) clearance for the Anorganic Bone Mineral with Collagen in Delivery Applicator, 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 October 30, 2017, 209 days after receiving the submission on April 4, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K171008 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2017
Decision Date October 30, 2017
Days to Decision 209 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.