Cleared Traditional

K863769 - EVACUATOR TIPS

K863769 is an FDA 510(k) clearance for EVACUATOR TIPS, manufactured by The Medical Group, Inc.. The device is a Class 1 Dental device with product code EHZ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K863769 · The Medical Group, Inc. · Dental device
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Oct 1986
Decision
35d
Days
Class 1
Risk

K863769 is an FDA 510(k) clearance for the EVACUATOR TIPS. Classified as Evacuator, Oral Cavity (product code EHZ), Class I - General Controls.

Submitted by The Medical Group, Inc. (Reno, US). The FDA issued a Cleared decision on October 30, 1986 after a review of 35 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 The Medical Group, Inc. devices

FDA 510(k) Submission Details - K863769

510(k) Number K863769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1986
Decision Date October 30, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
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 K863769.
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