Cleared Traditional

K962665 - A-DEC SELF-CONTAINED WATER SYSTEM

K962665 is the FDA 510(k) clearance for A-DEC SELF-CONTAINED WATER SYSTEM by A-Dec, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K962665 · A-Dec, Inc. · Dental device
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Aug 1996
Decision
44d
Days
Class 1
Risk

K962665 is an FDA 510(k) clearance for the A-DEC SELF-CONTAINED WATER SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 44 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 A-Dec, Inc. devices

Submission Details

510(k) Number K962665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date August 22, 1996
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
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 60
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K962665.
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A-DEC PERFORMER CONTROL UNIT
K960506 · A-Dec, Inc. · Mar 1996
A-DEC RADIUS 2122/2132
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A-DEC CASCADE 3072 WALLMOUNT
K935325 · A-Dec, Inc. · Apr 1994