Cleared Traditional

K872521 - DENTURE CLEANSERS

K872521 is an FDA 510(k) clearance for DENTURE CLEANSERS, manufactured by Dental Research Laboratories. The device is a Class 1 Dental device with product code JER cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K872521 · Dental Research Laboratories · Dental device
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Aug 1987
Decision
47d
Days
Class 1
Risk

K872521 is an FDA 510(k) clearance for the DENTURE CLEANSERS. Classified as Cleaner, Denture, Mechanical (product code JER), Class I - General Controls.

Submitted by Dental Research Laboratories (Palm Harbor, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3530 - 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 Dental Research Laboratories devices

FDA 510(k) Submission Details - K872521

510(k) Number K872521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date August 11, 1987
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

JER Device Classification - Class 1, General Controls

Product Code JER Cleaner, Denture, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3530
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.