Cleared Traditional

K183436 - OraCure

K183436 · Tbm Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
281d
Days
-
Risk

K183436 is an FDA 510(k) clearance for the OraCure. Classified as Oral Wound Dressing (product code OLR).

Submitted by Tbm Corporation (Gwangju, KR). The FDA issued a Cleared decision on September 18, 2019 after a review of 281 days - an extended review cycle.

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 Tbm Corporation devices

FDA 510(k) Submission Details - K183436

510(k) Number K183436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date September 18, 2019
Days to Decision 281 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
154d slower than avg
Panel avg: 127d · This submission: 281d
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 Consultant

KMC, Inc.
Ryan Hwang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLR Oral Wound Dressing

All 23
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K183436.
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
SUNTOUCH Dental Dressing
K173196 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2018
AFTAMED MOUTHWASH
K130959 · Bioplax Limited · Apr 2014
AONGEN DENTAL COLLAGEN MATRIX
K112568 · Aeon Astron Europe B.V. · Mar 2012