Cleared Traditional

K973876 - PROPHYFLEX 2

K973876 is the FDA 510(k) clearance for PROPHYFLEX 2 by Kavo America. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K973876 · Kavo America · Dental device
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Dec 1997
Decision
70d
Days
Class 1
Risk

K973876 is an FDA 510(k) clearance for the PROPHYFLEX 2, MODEL 2012. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kavo America (Chicago, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 70 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 Kavo America devices

Submission Details

510(k) Number K973876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1997
Decision Date December 19, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 78
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