Cleared Special

K031868 - PROPHYPEARLS

K031868 is an FDA 510(k) clearance for PROPHYPEARLS, manufactured by Kavo America. The device is a Class 1 Dental device with product code EFB cleared through the Special 510(k) pathway after a 22-day FDA review.

K031868 · Kavo America · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
22d
Days
Class 1
Risk

K031868 is an FDA 510(k) clearance for the PROPHYPEARLS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kavo America (Deer Field, US). The FDA issued a Cleared decision on July 9, 2003 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031868

510(k) Number K031868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2003
Decision Date July 09, 2003
Days to Decision 22 days
Submission Type Special
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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

EFB Device Classification - Class 1, General Controls

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 262
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K031868.
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
K032234 · Mk-Dent GmbH · Oct 2003
DENTISEPTIC HPC
K031851 · Bethel, Inc. · Aug 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
K022535 · Microtech · Oct 2002
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
K022119 · Electro Medical Systems SA · Jul 2002
KAVO QUATTROCARE
K012308 · Kavo America · Jun 2002
K031868 · PROPHYPEARLS
Download PDF FDA Summary Kavo America