Cleared Traditional

K983847 - MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT

K983847 is an FDA 510(k) clearance for MODIFICATION OF: ODYSSEY I DENTAL WATER..., 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 32-day FDA review.

K983847 · Germiphene Corp. · Dental device
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Dec 1998
Decision
32d
Days
Class 1
Risk

K983847 is an FDA 510(k) clearance for the MODIFICATION OF: 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 December 1, 1998 after a review of 32 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 Germiphene Corp. devices

FDA 510(k) Submission Details - K983847

510(k) Number K983847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date December 01, 1998
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
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 110
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K983847.
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ULTRACAM
K973410 · W. Edward Johansen · Oct 1998
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K981937 · Welch Allyn, Inc. · Aug 1998