Cleared Traditional

K051657 - A-DEC SELF-CONTAINED WATER SYSTEM

K051657 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 70-day FDA review.

K051657 · A-Dec, Inc. · Dental device
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Aug 2005
Decision
70d
Days
Class 1
Risk

K051657 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 30, 2005 after a review of 70 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 K051657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2005
Decision Date August 30, 2005
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
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 K051657.
A-DEC 200 DENTAL SYSTEM
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A-DEC 334/335 DELIVERY SYSTEM
K082985 · A-Dec, Inc. · Dec 2008
SPACELINE EMCIA, MODEL CU580
K043496 · J. Morita USA, Inc. · Feb 2005
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757 · A-Dec, Inc. · Dec 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756 · A-Dec, Inc. · Dec 2003