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FDA 510(k)

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

K-Number: K171542 · 2018-03-16

ApplicantDr. Harold Katz, LLC (Dba Therabreath
Decision Date2018-03-16
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is a medical device manufactured by Dr. Harold Katz, LLC (Dba Therabreath. It received FDA 510(k) clearance on 2018-03-16 under approval number K171542. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Dr. Harold Katz, LLC (Dba Therabreath. The 510(k) number is K171542.

When was TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges approved by the FDA?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges received FDA 510(k) clearance on 2018-03-16, under approval number K171542.

What company makes TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is manufactured by Dr. Harold Katz, LLC (Dba Therabreath.

What is the FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges?

The FDA product code for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges is LFD.

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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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