Cleared Traditional

K903452 - A-DEC IC CONTROL HEAD

K903452 is an FDA 510(k) clearance for A-DEC IC CONTROL HEAD, 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 85-day FDA review.

K903452 · A-Dec, Inc. · Dental device
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Oct 1990
Decision
85d
Days
Class 1
Risk

K903452 is an FDA 510(k) clearance for the A-DEC IC CONTROL HEAD. 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 October 24, 1990 after a review of 85 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 - K903452

510(k) Number K903452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 24, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K903452.
ASEPTIMINI UNIT, ADU-10
K905401 · Aseptico, Inc. · Feb 1991
ORAL PHARYNGEAL CLEANSING DEVICE
K905011 · Concord/Portex · Jan 1991
A-DEC PAC I PORTABLE UNIT
K903451 · A-Dec, Inc. · Oct 1990
A-DEC IC MICRO-CART
K903453 · A-Dec, Inc. · Oct 1990
A-DEC DECADE CUSPIDOR
K903455 · A-Dec, Inc. · Oct 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · Sage Products, Inc. · Aug 1990