Cleared Traditional

K821155 - DENTAL FLOSS HOLDER

K821155 is an FDA 510(k) clearance for DENTAL FLOSS HOLDER, manufactured by Eric L. Smith. The device is a Class 1 Dental device with product code JES cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K821155 · Eric L. Smith · Dental device
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May 1982
Decision
28d
Days
Class 1
Risk

K821155 is an FDA 510(k) clearance for the DENTAL FLOSS HOLDER. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by Eric L. Smith (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6390 - 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 Eric L. Smith devices

FDA 510(k) Submission Details - K821155

510(k) Number K821155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date May 24, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

JES Device Classification - Class 1, General Controls

Product Code JES Floss, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6390
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.