Cleared Traditional

K162158 - Porcine Anorganic Bone Mineral in Delivery Applicator

K162158 is an FDA 510(k) clearance for Porcine Anorganic Bone Mineral in Deliv..., manufactured by Collagen Matrix, Inc.. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K162158 · Collagen Matrix, Inc. · Dental device
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Feb 2017
Decision
191d
Days
Class 2
Risk

K162158 is an FDA 510(k) clearance for the Porcine 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 February 9, 2017 after a review of 191 days - an extended review cycle.

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

FDA 510(k) Submission Details - K162158

510(k) Number K162158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date February 09, 2017
Days to Decision 191 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
64d slower than avg
Panel avg: 127d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPM Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K162158.
OSSIX BONE
K163714 · Datum Dental, Ltd. · Jul 2017
Anorganic Bone Mineral in Delivery Applicator
K170541 · Collagen Matrix, Inc. · Jul 2017
DSM Biomedical Dental Bone Graft
K170245 · Kensey Nash Corporation Dba Dsm Biomedical · May 2017
A-Oss
K151542 · Hiossen, Inc. · Aug 2016
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079 · Nibec Co., Ltd. · Dec 2015
InterOss
K151209 · Sigmagraft, Inc. · Nov 2015