Cleared Traditional

K170541 - Anorganic Bone Mineral in Delivery Appl...

K170541 is the FDA 510(k) clearance for Anorganic Bone Mineral in Delivery Appl... by Collagen Matrix, Inc.. It is a Class 2 Dental device (product code NPM) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K170541 · Collagen Matrix, Inc. · Dental device
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Jul 2017
Decision
134d
Days
Class 2
Risk

K170541 is an FDA 510(k) clearance for the Anorganic Bone Mineral in Delivery Applicator. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on July 7, 2017 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Collagen Matrix, Inc. devices

Submission Details

510(k) Number K170541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPM Bone Grafting Material, Animal Source

All 19
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K170541.
Straumann cerabone
K173594 · Institut Straumann AG · Oct 2018
The Graft Natural Bone Substitute
K173188 · Purgo Biologics, Inc. · Jul 2018
Anorganic Bone Mineral with Collagen in Delivery Applicator
K171008 · Collagen Matrix, Inc. · Oct 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158 · Collagen Matrix, Inc. · Feb 2017
PORCINE ANORGANIC BONE MINERAL
K140714 · Collagen Matrix, Inc. · Jul 2014
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
K043034 · Collagen Matrix, Inc. · Aug 2005