Cleared Traditional

MucoLock Oral Gel (K203091) - FDA 510(k) Clearance

K203091 · Pcca, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
122d
Days
-
Risk

K203091 is an FDA 510(k) clearance for the MucoLock Oral Gel. Classified as Oral Wound Dressing (product code OLR).

Submitted by Pcca, Inc. (Houston, US). The FDA issued a Cleared decision on February 12, 2021 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pcca, Inc. devices

Submission Details

510(k) Number K203091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date February 12, 2021
Days to Decision 122 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
5d faster than avg
Panel avg: 127d · This submission: 122d
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 13
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K203091.
PerioStom Dental Dressing
K221428 · Forward Science, LLC · Dec 2022
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021
Silatrix Oral Gel
K202000 · Sa3, LLC · Nov 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K193336 · Synedgen, Inc. · May 2020
Orapeutic
K191987 · Forward Science · Nov 2019