Cleared Traditional

K903718 - OROSCOPE MODEL NUMBER COS-100

K903718 is an FDA 510(k) clearance for OROSCOPE MODEL NUMBER COS-100, manufactured by Cygnus Instruments, Inc.. The device is a Class 1 Dental device with product code EHZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K903718 · Cygnus Instruments, Inc. · Dental device
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Nov 1990
Decision
85d
Days
Class 1
Risk

K903718 is an FDA 510(k) clearance for the OROSCOPE MODEL NUMBER COS-100. Classified as Evacuator, Oral Cavity (product code EHZ), Class I - General Controls.

Submitted by Cygnus Instruments, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 85 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 Cygnus Instruments, Inc. devices

FDA 510(k) Submission Details - K903718

510(k) Number K903718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date November 09, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K903718.
IMTEC BONE COLLECTOR SYSTEM
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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