Cleared Traditional

K822411 - SYSTEM 80 FACEPLATE-IN-THE-EAR #F1

K822411 is an FDA 510(k) clearance for SYSTEM 80 FACEPLATE-IN-THE-EAR #F1, manufactured by Western Advanced Technology, Inc.. The device is a Class 1 Dental device with product code EIB cleared through the Traditional 510(k) pathway after a 336-day FDA review.

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

FDA 510(k) Submission Details - K822411

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.

EIB Device Classification - Class 1, General Controls

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.