Cleared Traditional

Anorganic Bone Mineral in Delivery Applicator

K170541 · Collagen Matrix, Inc. · Dental

Jul 2017

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K170541 is an FDA 510(k) clearance for the Anorganic Bone Mineral 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 July 7, 2017, 134 days after receiving the submission on February 23, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K170541 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2017
Decision Date	July 07, 2017
Days to Decision	134 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.