Cleared Traditional

K202183 - Porcine Mineral Collagen Composite

K202183 is the FDA 510(k) clearance for Porcine Mineral Collagen Composite by Collagen Matrix, Inc.. It is a Class 2 Dental device (product code NPM) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K202183 · Collagen Matrix, Inc. · Dental device
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Apr 2021
Decision
241d
Days
Class 2
Risk

K202183 is an FDA 510(k) clearance for the Porcine Mineral Collagen Composite. 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 April 2, 2021 after a review of 241 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

Submission Details

510(k) Number K202183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2020
Decision Date April 02, 2021
Days to Decision 241 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
114d slower than avg
Panel avg: 127d · This submission: 241d
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 K202183.
S1
K231672 · Medpark Co., Ltd. · Oct 2023
InterOss Collagen
K221808 · Sigmagraft, Inc. · Mar 2023
Wishbone HA
K211551 · Wishbone SA · Aug 2021
Porcine Mineral Collagen Composite Moldable
K201859 · Collagen Matrix, Inc. · Sep 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · Dsm Biomedical · Sep 2020
The Graft Bone Substitute
K191737 · Purgo Biologics, Inc. · Feb 2020