PerioStom Dental Dressing

FDA 510(k) K221428 · Forward Science, LLC

Substantially Equivalent

510(k) numberK221428

Submission

Device name
PerioStom Dental Dressing
Applicant
Forward Science, LLC
Houston, TX, US
Received
May 16, 2022
Decision date
December 22, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLR – Oral Wound Dressing
Device class
Unclassified

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other 510(k)s with product code OLR

510(k)DeviceApplicantDecision
K260120NaturaJel™ Oral Wound Care KitOLR · Traditional HCS Innovation, LLC08/05/2026SE
K251908Emanate TrayOLR · Traditional Emanate Biomedical07/29/2026SE
K260126Curajel™ Oral GelOLR · Traditional USpharma, Ltd.06/15/2026SE
K253816MuCover (proposed name) Oral Wound DressingOLR · Traditional MoleculeX Co., Ltd.05/21/2026SE
K253758Dental Cone; Dental SpongeOLR · Special Medizin Produkte Neustadt GmbH (Mpn)12/18/2025SE
K252425Silatrix Oral GelOLR · Traditional Sa3, LLC10/23/2025SE
K241283Elemental GranulateOLR · Traditional Zinkh NV01/03/2025SE
K230529HealiAid Dental Collagen Wound DressingOLR · Traditional Maxigen Biotech, Inc.11/22/2023SE
K211851Ora-AidOLR · Traditional Tbm Corporation01/11/2022SE
K210211PuraStat-OMOLR · Traditional 3-D Matrix, Inc.10/08/2021SE

More from 3-D Matrix, Inc.

510(k)DeviceDecision
K191987OrapeuticOLR · Traditional 11/27/2019SE
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K123169OralidNXV · Traditional 03/13/2013SE

Questions and answers

When was PerioStom Dental Dressing cleared by the FDA?

PerioStom Dental Dressing (K221428) received a 510(k) decision of Substantially Equivalent on December 22, 2022, 220 days after the submission was received.

What is the product code of K221428?

The FDA product code is OLR – Oral Wound Dressing, a Unclassified device.