Cleared Traditional

K873209 - PLAQUE-SWEEP

K873209 is the FDA 510(k) clearance for PLAQUE-SWEEP by Dentsply Intl.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K873209 · Dentsply Intl. · Dental device
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Aug 1987
Decision
11d
Days
Class 1
Risk

K873209 is an FDA 510(k) clearance for the PLAQUE-SWEEP. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 25, 1987 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K873209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date August 25, 1987
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 127d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 84
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K873209.
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K894606 · Micro-Aire Surgical Instruments, Inc. · Oct 1989
MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL
K850597 · Micro-Aire Surgical Instruments, Inc. · Mar 1985
CUTTER JET
K801651 · Cutter Laboratories, Inc. · Aug 1980