Cleared Traditional

K964796 - ODYSSEY I DENTAL WATER UNIT

K964796 is an FDA 510(k) clearance for ODYSSEY I DENTAL WATER UNIT, manufactured by Germiphene Corp.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 166-day FDA review.

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

FDA 510(k) Submission Details - K964796

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 109
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K964619 · Sds Dental, Inc. · Jan 1997