Cleared Traditional

K202689 - Dentilube Spray

K202689 · Oxy2plus, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
353d
Days
-
Risk

K202689 is an FDA 510(k) clearance for the Dentilube Spray. Classified as Saliva, Artificial (product code LFD).

Submitted by Oxy2plus, LLC (Rosemead, US). The FDA issued a Cleared decision on September 3, 2021 after a review of 353 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxy2plus, LLC devices

FDA 510(k) Submission Details - K202689

510(k) Number K202689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2020
Decision Date September 03, 2021
Days to Decision 353 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
226d slower than avg
Panel avg: 127d · This submission: 353d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 17
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K202689.
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GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
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Oral-B Dry Mouth Oral Rinse
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Oral-B Dry Mouth Oral Rinse
K201277 · The Procter & Gamble Company · Sep 2020
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839 · Oralabs, Inc. · Nov 2019