Cleared Traditional

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (K822411) - FDA 510(k) Clearance

Class I Dental device.

K822411 · Western Advanced Technology, Inc. · Dental device
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Jul 1983
Decision
336d
Days
Class 1
Risk

K822411 is an FDA 510(k) clearance for the SYSTEM 80 FACEPLATE-IN-THE-EAR #F1. Classified as Syringe, Irrigating (dental) (product code EIB), Class I - General Controls.

Submitted by Western Advanced Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Western Advanced Technology, Inc. devices

Submission Details

510(k) Number K822411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1982
Decision Date July 12, 1983
Days to Decision 336 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 127d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIB Syringe, Irrigating (dental)
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.