Cleared Traditional

K152600 - Collagen Dental Wound Dressings

K152600 · Collagen Matrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
286d
Days
-
Risk

K152600 is an FDA 510(k) clearance for the Collagen Dental Wound Dressings. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on June 23, 2016 after a review of 286 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K152600

510(k) Number K152600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2015
Decision Date June 23, 2016
Days to Decision 286 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 115d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K152600.
KeraStat(R) Gel
K162759 · Keranetics, LLC · Jun 2017
ABCcolla Collagen Matrix
K162348 · Acro Biomedical Co., Ltd. · May 2017
Flowable Wound Matrix
K160136 · Cook Biotech Incorporated · Sep 2016
MicroMatrix
K153754 · Acell, Inc. · Mar 2016
PriMatrix Dermal Repair Scaffold
K153690 · Tei Biosciences, Inc. · Feb 2016
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015