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FDA 510(k)

Ora-Aid

K-Number: K211851 · 2022-01-11

ApplicantTbm Corporation
Decision Date2022-01-11
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Ora-Aid is the device name listed in this FDA 510(k) record. The listed applicant is Tbm Corporation. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K211851. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ora-Aid?

Ora-Aid is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Tbm Corporation. The 510(k) number is K211851.

When did Ora-Aid receive FDA 510(k) clearance?

Ora-Aid received FDA 510(k) clearance on 2022-01-11, under 510(k) number K211851.

Who is the listed applicant for Ora-Aid?

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

What is the FDA product code for Ora-Aid?

The FDA product code for Ora-Aid is OLR.

Related Clinical Trials

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.

NCT07523802Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal StentRECRUITING

Other records listing Tbm Corporation 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.

K183436OraCure

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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