Cleared Traditional

K000966 - 4631 DUO DELIVERY SYSTEM

K000966 is an FDA 510(k) clearance for 4631 DUO 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 37-day FDA review.

K000966 · A-Dec, Inc. · Dental device
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May 2000
Decision
37d
Days
Class 1
Risk

K000966 is an FDA 510(k) clearance for the 4631 DUO 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 May 3, 2000 after a review of 37 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 - K000966

510(k) Number K000966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date May 03, 2000
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 K000966.
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
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SOPRO595 INTRA ORAL CAMERA
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MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
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4635 ASSISTANT'S INSTRUMENTATION
K000967 · A-Dec, Inc. · May 2000
3181 DUO DELIVERY SYSTEM
K000968 · A-Dec, Inc. · May 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112 · Dentsply Intl. · Apr 2000