Cleared Traditional

CA AND ST (K926155) - FDA 510(k) Clearance

Class I Dental device.

K926155 · Dabi-Atlante America Corp. · Dental device
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Mar 1994
Decision
452d
Days
Class 1
Risk

K926155 is an FDA 510(k) clearance for the CA AND ST. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dabi-Atlante America Corp. (Tampa, US). The FDA issued a Cleared decision on March 4, 1994 after a review of 452 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dabi-Atlante America Corp. devices

Submission Details

510(k) Number K926155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date March 04, 1994
Days to Decision 452 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
325d slower than avg
Panel avg: 127d · This submission: 452d
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 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K926155.
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DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
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K897101 · Dentsply Intl. · Mar 1990
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987