Cleared Traditional

K230529 - HealiAid Dental Collagen Wound Dressing (FDA 510(k) Clearance)

K230529 · Maxigen Biotech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
268d
Days
-
Risk

K230529 is an FDA 510(k) clearance for the HealiAid Dental Collagen Wound Dressing. Classified as Oral Wound Dressing (product code OLR).

Submitted by Maxigen Biotech, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on November 22, 2023 after a review of 268 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 Maxigen Biotech, Inc. devices

Submission Details

510(k) Number K230529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2023
Decision Date November 22, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 127d · This submission: 268d
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 K230529.
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PerioStom Dental Dressing
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K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021