Cleared Traditional

K962665 - A-DEC SELF-CONTAINED WATER SYSTEM

K962665 is an FDA 510(k) clearance for A-DEC SELF-CONTAINED WATER SYSTEM, manufactured by A-Dec, Inc.. The device is a Class 1 Dental device with 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

FDA 510(k) Submission Details - K962665

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.

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 171
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K962665.
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K964619 · Sds Dental, Inc. · Jan 1997
CDR-CAM
K963778 · Schick Technologies, Inc. · Nov 1996
PROSTYLE COMPACT
K961420 · Planmeca Oy · Sep 1996
SPIRIT S1/S2
K962071 · Pelton & Crane Co. · Aug 1996
GENERAL PURPOSE DENTAL TRAY
K962527 · Medcare Medical Group, Inc. · Aug 1996
PORTA'PURE/DENTAL
K961409 · Water Solution Technologies · Jun 1996