FDA 510(k)

Dentilube Spray

K-Number: K202689 · 2021-09-03

Decision Date2021-09-03

Product CodeLFD

DecisionSubstantially Equivalent

Device Summary

Dentilube Spray is the device name listed in this FDA 510(k) record. The listed applicant is Oxy2plus, LLC. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K202689. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentilube Spray?

Dentilube Spray is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Oxy2plus, LLC. The 510(k) number is K202689.

When did Dentilube Spray receive FDA 510(k) clearance?

Dentilube Spray received FDA 510(k) clearance on 2021-09-03, under 510(k) number K202689.

Who is the listed applicant for Dentilube Spray?

The FDA 510(k) record lists Oxy2plus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentilube Spray?

The FDA product code for Dentilube Spray is LFD.

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 Care K250390CloSYS® 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) Limited K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company

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.