Cleared Traditional

K221428 - PerioStom Dental Dressing (FDA 510(k) Clearance)

K221428 · Forward Science, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2022
Decision
220d
Days
-
Risk

K221428 is an FDA 510(k) clearance for the PerioStom Dental Dressing. Classified as Oral Wound Dressing (product code OLR).

Submitted by Forward Science, LLC (Houston, US). The FDA issued a Cleared decision on December 22, 2022 after a review of 220 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 Forward Science, LLC devices

Submission Details

510(k) Number K221428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2022
Decision Date December 22, 2022
Days to Decision 220 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
106d slower than avg
Panel avg: 114d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 38
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K221428.
Dental Cone
K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dec 2025
Silatrix Oral Gel
K252425 · Sa3, LLC · Oct 2025
Elemental Granulate
K241283 · Zinkh NV · Jan 2025
HealiAid Dental Collagen Wound Dressing
K230529 · Maxigen Biotech, Inc. · Nov 2023
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021