Cleared Traditional

ODYSSEY I DENTAL WATER UNIT (K964796) - FDA 510(k) Clearance

Class I Dental device.

K964796 · Germiphene Corp. · Dental device
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May 1997
Decision
166d
Days
Class 1
Risk

K964796 is an FDA 510(k) clearance for the ODYSSEY I DENTAL WATER UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Germiphene Corp. (Brantford, Ont, CA). The FDA issued a Cleared decision on May 14, 1997 after a review of 166 days - an extended review 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: 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 Germiphene Corp. devices

Submission Details

510(k) Number K964796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date May 14, 1997
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
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 - EIA Unit, Operative Dental

All 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K964796.
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
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K000112 · Dentsply Intl. · Apr 2000
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979