Cleared Traditional

K974487 - SEAC ADVANCED DENTAL SYSTEM - MODEL 2001

K974487 is the FDA 510(k) clearance for SEAC ADVANCED DENTAL SYSTEM - MODEL 2001 by Asi Medical, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K974487 · Asi Medical, Inc. · Dental device
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Feb 1998
Decision
84d
Days
Class 1
Risk

K974487 is an FDA 510(k) clearance for the SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Asi Medical, Inc. (Centennial, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 84 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 Asi Medical, Inc. devices

Submission Details

510(k) Number K974487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date February 18, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 54
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K974487.
QUANTEC-E IRRIGATION SYSTEM
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WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
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A-DEC SELF-CONTAINED WATER SYSTEM
K962665 · A-Dec, Inc. · Aug 1996
A-DEC PERFORMER CONTROL UNIT
K960506 · A-Dec, Inc. · Mar 1996
A-DEC RADIUS 2122/2132
K940893 · A-Dec, Inc. · Jul 1994