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FDA 510(k)

ALOCLAIR ORAL GEL

K-Number: K040950 · 2004-06-21

ApplicantSinclair Pharmaceuticals, Ltd.
Decision Date2004-06-21
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

ALOCLAIR ORAL GEL is the device name listed in this FDA 510(k) record. The listed applicant is Sinclair Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2004-06-21 under 510(k) number K040950. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALOCLAIR ORAL GEL?

ALOCLAIR ORAL GEL is a medical device that received FDA 510(k) clearance on 2004-06-21. The listed applicant is Sinclair Pharmaceuticals, Ltd.. The 510(k) number is K040950.

When did ALOCLAIR ORAL GEL receive FDA 510(k) clearance?

ALOCLAIR ORAL GEL received FDA 510(k) clearance on 2004-06-21, under 510(k) number K040950.

Who is the listed applicant for ALOCLAIR ORAL GEL?

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

What is the FDA product code for ALOCLAIR ORAL GEL?

The FDA product code for ALOCLAIR ORAL GEL is OLR.

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Other records listing Sinclair Pharmaceuticals, Ltd. 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.

K050158SINCLAIR SEBORRHEA EMULSIONK042722ALOCLAIR ORAL SPRAYK024148SALINUM, ORCLAIRK024367SINCLAIR WOUND AND SKIN EMULSIONK023046SST SALIVA SUPPORTING TABLETSK023155ALOCLAIR ORAL RINSE

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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

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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