Cleared Traditional

ORALUBE (K090457) - FDA 510(k) Clearance

Class I Dental device.

K090457 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
87d
Days
Class 1
Risk

K090457 is an FDA 510(k) clearance for the ORALUBE. Classified as Oral Lubricant (product code ONK), Class I - General Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on May 21, 2009 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 880.6375 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corporation devices

Submission Details

510(k) Number K090457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date May 21, 2009
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ONK Oral Lubricant
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
Definition An Oral Lubricant To Be Used Adjacent To Hard And Soft Tissue And The Lips To Prevent Adherence Of Dental Cement; Placement Of A Rubber Dam; And To Prevent The Lips From Drying And Cracking During Dental Procedures.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.