Cleared Traditional

MULTI-UNIT, MULTI-PURPOSE DEVICE (K813638) - FDA 510(k) Clearance

Class I Dental device.

K813638 · The Scott & Fetzer Co. · Dental device
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May 1982
Decision
128d
Days
Class 1
Risk

K813638 is an FDA 510(k) clearance for the MULTI-UNIT, MULTI-PURPOSE DEVICE. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by The Scott & Fetzer Co. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1982 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 The Scott & Fetzer Co. devices

Submission Details

510(k) Number K813638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1981
Decision Date May 07, 1982
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 127d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.