Cleared Traditional

K895164 - EAGLE DS (FDA 510(k) Clearance)

Class I Dental device.

K895164 · American Sterilizer Co. · Dental device
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Nov 1989
Decision
87d
Days
Class 1
Risk

K895164 is an FDA 510(k) clearance for the EAGLE DS. Classified as Sterilizer, Boiling Water (product code ECG), Class I - General Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6710 - 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 American Sterilizer Co. devices

Submission Details

510(k) Number K895164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1989
Decision Date November 17, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECG Sterilizer, Boiling Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6710
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.