Cleared Traditional

K202689 - Dentilube Spray (FDA 510(k) Clearance)

K202689 · Oxy2plus, LLC · Dental device
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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

Submission Details

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.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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