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FDA 510(k)

ORAL BALANCE LIQUID/ GEL

K-Number: K061331 · 2006-07-25

ApplicantLaclede, Inc.
Decision Date2006-07-25
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

ORAL BALANCE LIQUID/ GEL is the device name listed in this FDA 510(k) record. The listed applicant is Laclede, Inc.. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K061331. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL BALANCE LIQUID/ GEL?

ORAL BALANCE LIQUID/ GEL is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Laclede, Inc.. The 510(k) number is K061331.

When did ORAL BALANCE LIQUID/ GEL receive FDA 510(k) clearance?

ORAL BALANCE LIQUID/ GEL received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061331.

Who is the listed applicant for ORAL BALANCE LIQUID/ GEL?

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

What is the FDA product code for ORAL BALANCE LIQUID/ GEL?

The FDA product code for ORAL BALANCE LIQUID/ GEL is LFD.

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Other records listing Laclede, Inc. 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.

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Related Devices (Code: LFD)

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.

K253778Allday Moisturizing RinseElevate Oral CareK250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) LimitedK231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLCK202689Dentilube SprayOxy2plus, 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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