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FDA 510(k)

DRY MOUTH MOUTHWASH

K-Number: K111250 · 2012-04-27

ApplicantDr. Fresh, Inc.
Decision Date2012-04-27
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

DRY MOUTH MOUTHWASH is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Fresh, Inc.. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K111250. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRY MOUTH MOUTHWASH?

DRY MOUTH MOUTHWASH is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Dr. Fresh, Inc.. The 510(k) number is K111250.

When did DRY MOUTH MOUTHWASH receive FDA 510(k) clearance?

DRY MOUTH MOUTHWASH received FDA 510(k) clearance on 2012-04-27, under 510(k) number K111250.

Who is the listed applicant for DRY MOUTH MOUTHWASH?

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

What is the FDA product code for DRY MOUTH MOUTHWASH?

The FDA product code for DRY MOUTH MOUTHWASH is LFD.

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.

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Other records listing Dr. Fresh, 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.

K110888ABSOLUTE WHITE LIGHT

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

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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