FDA 510(k)

PerioStom Dental Dressing

K-Number: K221428 · 2022-12-22

Decision Date2022-12-22

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

PerioStom Dental Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Forward Science, LLC. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K221428. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PerioStom Dental Dressing?

PerioStom Dental Dressing is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Forward Science, LLC. The 510(k) number is K221428.

When did PerioStom Dental Dressing receive FDA 510(k) clearance?

PerioStom Dental Dressing received FDA 510(k) clearance on 2022-12-22, under 510(k) number K221428.

Who is the listed applicant for PerioStom Dental Dressing?

The FDA 510(k) record lists Forward Science, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PerioStom Dental Dressing?

The FDA product code for PerioStom Dental Dressing is OLR.

Other records listing Forward Science, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191987Orapeutic

Related Devices (Code: OLR)

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

Official Source

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