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510(k) K171542

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges by Dr. Harold Katz, LLC (Dba Therabreath — Product Code LFD

K171542 is an FDA 510(k) premarket notification submitted by Dr. Harold Katz, LLC (Dba Therabreath for the device "TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges". The FDA issued a decision of Substantially Equivalent on March 16, 2018. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
May 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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FDA data resources