Cleared Traditional

K211851 - Ora-Aid (FDA 510(k) Clearance)

K211851 · Tbm Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2022
Decision
210d
Days
-
Risk

K211851 is an FDA 510(k) clearance for the Ora-Aid. Classified as Oral Wound Dressing (product code OLR).

Submitted by Tbm Corporation (Gwangju, KR). The FDA issued a Cleared decision on January 11, 2022 after a review of 210 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 Tbm Corporation devices

Submission Details

510(k) Number K211851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2021
Decision Date January 11, 2022
Days to Decision 210 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
96d slower than avg
Panel avg: 114d · This submission: 210d
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 Consultant

KMC, Inc.
Milly Milly

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 38
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K211851.
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