Cleared Traditional

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (K897195) - FDA 510(k) Clearance

Class I Dental device.

K897195 · A Company, Inc. · Dental device
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May 1990
Decision
153d
Days
Class 1
Risk

K897195 is an FDA 510(k) clearance for the A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD). Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by A Company, Inc. (San Diego, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 153 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all A Company, Inc. devices

Submission Details

510(k) Number K897195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1989
Decision Date May 31, 1990
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.