Cleared Traditional

K012308 - KAVO QUATTROCARE (FDA 510(k) Clearance)

Class I Dental device.

K012308 · Kavo America · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
338d
Days
Class 1
Risk

K012308 is an FDA 510(k) clearance for the KAVO QUATTROCARE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on June 26, 2002 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kavo America devices

Submission Details

510(k) Number K012308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date June 26, 2002
Days to Decision 338 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 127d · This submission: 338d
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 260
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K012308.
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