Cleared Traditional

K201859 - Porcine Mineral Collagen Composite Mold...

K201859 is the FDA 510(k) clearance for Porcine Mineral Collagen Composite Mold... by Collagen Matrix, Inc.. It is a Class 2 Dental device (product code NPM) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

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

K201859 is an FDA 510(k) clearance for the Porcine Mineral Collagen Composite Moldable. 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 September 11, 2020 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Collagen Matrix, Inc. devices

Submission Details

510(k) Number K201859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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 K201859.
InterOss Collagen
K221808 · Sigmagraft, Inc. · Mar 2023
Wishbone HA
K211551 · Wishbone SA · Aug 2021
Porcine Mineral Collagen Composite
K202183 · Collagen Matrix, Inc. · Apr 2021
DSM Biomedical Dental Bone Graft Plus
K193212 · Dsm Biomedical · Sep 2020
The Graft Bone Substitute
K191737 · Purgo Biologics, Inc. · Feb 2020
Straumann cerabone
K173594 · Institut Straumann AG · Oct 2018