Cleared Traditional

MINIFLEX AND PERSONAL UNIT (K912997) - FDA 510(k) Clearance

Class I Dental device.

K912997 · Dabi-Atlante America Corp. · Dental device
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Oct 1991
Decision
114d
Days
Class 1
Risk

K912997 is an FDA 510(k) clearance for the MINIFLEX AND PERSONAL UNIT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Dabi-Atlante America Corp. (Tampa, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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. Standard predicate reliance. 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 Dabi-Atlante America Corp. devices

Submission Details

510(k) Number K912997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date October 30, 1991
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.