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FDA 510(k)

REXASTOM ORAL EASE

K-Number: K082553 · 2008-11-21

ApplicantRexaderm, Inc.
Decision Date2008-11-21
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

REXASTOM ORAL EASE is the device name listed in this FDA 510(k) record. The listed applicant is Rexaderm, Inc.. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K082553. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXASTOM ORAL EASE?

REXASTOM ORAL EASE is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Rexaderm, Inc.. The 510(k) number is K082553.

When did REXASTOM ORAL EASE receive FDA 510(k) clearance?

REXASTOM ORAL EASE received FDA 510(k) clearance on 2008-11-21, under 510(k) number K082553.

Who is the listed applicant for REXASTOM ORAL EASE?

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

What is the FDA product code for REXASTOM ORAL EASE?

The FDA product code for REXASTOM ORAL EASE is OLR.

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ 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.

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