Cleared Traditional

K203091 - MucoLock Oral Gel

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

FDA 510(k) Submission Details - K203091

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.

OLR Device Classification - Class 0,

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