Cleared Traditional

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839) - FDA 510(k) Clearance

K181839 · Oralabs, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
498d
Days
-
Risk

K181839 is an FDA 510(k) clearance for the CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray. Classified as Saliva, Artificial (product code LFD).

Submitted by Oralabs, Inc. (Parker, US). The FDA issued a Cleared decision on November 21, 2019 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Oralabs, Inc. devices

Submission Details

510(k) Number K181839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2018
Decision Date November 21, 2019
Days to Decision 498 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
371d slower than avg
Panel avg: 127d · This submission: 498d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K181839.
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