Cleared Traditional

HealiAid Dental Collagen Wound Dressing

K230529 · Maxigen Biotech, Inc. · Dental
Nov 2023
Decision
268d
Days
—
Risk

About This 510(k) Submission

K230529 is an FDA 510(k) clearance for the HealiAid Dental Collagen Wound Dressing, a Oral Wound Dressing, submitted by Maxigen Biotech, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on November 22, 2023, 268 days after receiving the submission on February 27, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K230529 FDA.gov
FDA Decision Cleared 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

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.