Cleared Traditional

K082985 - A-DEC 334/335 DELIVERY SYSTEM

K082985 is an FDA 510(k) clearance for A-DEC 334/335 DELIVERY 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 71-day FDA review.

K082985 · A-Dec, Inc. · Dental device
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Dec 2008
Decision
71d
Days
Class 1
Risk

K082985 is an FDA 510(k) clearance for the A-DEC 334/335 DELIVERY 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 December 17, 2008 after a review of 71 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.

FDA 510(k) Submission Details - K082985

510(k) Number K082985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2008
Decision Date December 17, 2008
Days to Decision 71 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: 128d · This submission: 71d
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 284
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K082985.
MODEL GDCH-2000
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PLANMECA SOVEREIGN
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CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
K081237 · Craftmaster Contour Equipment, Inc. · Aug 2008
WESTAR SERIES DENTAL UNITS
K082294 · Westar Medical Products, Inc. · Aug 2008
K082985 · A-DEC 334/335 DELIVERY SYSTEM
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