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FDA 510(k)

HealiAid Dental Collagen Wound Dressing

K-Number: K230529 · 2023-11-22

ApplicantMaxigen Biotech, Inc.
Decision Date2023-11-22
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

HealiAid Dental Collagen Wound Dressing is a medical device manufactured by Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2023-11-22 under approval number K230529. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealiAid Dental Collagen Wound Dressing?

HealiAid Dental Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-11-22. It is manufactured by Maxigen Biotech, Inc.. The 510(k) number is K230529.

When was HealiAid Dental Collagen Wound Dressing approved by the FDA?

HealiAid Dental Collagen Wound Dressing received FDA 510(k) clearance on 2023-11-22, under approval number K230529.

What company makes HealiAid Dental Collagen Wound Dressing?

HealiAid Dental Collagen Wound Dressing is manufactured by Maxigen Biotech, Inc..

What is the FDA product code for HealiAid Dental Collagen Wound Dressing?

The FDA product code for HealiAid Dental Collagen Wound Dressing is OLR.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Maxigen Biotech, Inc.

K223126SurgiAid® Collagen Wound Dressing K242100SurgiAid Collagen Wound Dressing (HA)

Related Devices (Code: OLR)

K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd. K191987OrapeuticForward Science K183436OraCureTbm Corporation K202000Silatrix Oral GelSa3, LLC K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc. K210211PuraStat-OM3-D Matrix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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