Cleared Traditional

K911072 - SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR

K911072 is an FDA 510(k) clearance for SUPER EVACRETRACTOR, manufactured by A & F Products. The device is a Class 1 Dental device with product code EHZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K911072 · A & F Products · Dental device
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May 1991
Decision
65d
Days
Class 1
Risk

K911072 is an FDA 510(k) clearance for the SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR. Classified as Evacuator, Oral Cavity (product code EHZ), Class I - General Controls.

Submitted by A & F Products (Santa Ana, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 A & F Products devices

FDA 510(k) Submission Details - K911072

510(k) Number K911072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date May 15, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

EHZ Device Classification - Class 1, General Controls

Product Code EHZ Evacuator, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EHZ Evacuator, Oral Cavity

Devices cleared under the same product code (EHZ) and FDA review panel - the closest regulatory comparables to K911072.
IMTEC BONE COLLECTOR SYSTEM
K973248 · Imtec Corp. · Nov 1997
TITANIUM SUCTION TIP
K874401 · Implant Innovations International, Inc. · Nov 1987
SPACELINE HIGH VOLUME EVACUATION HANDPIE
K801682 · Pacific Dental Corp. · Aug 1980
MVS UNIT, MODEL SEU-8 AND DEU-8, 80
K782068 · Dentsply Intl. · Jan 1979
MVS-MODEL SEU-6, DEU-6
K781488 · Dentsply Intl. · Sep 1978