Cleared Traditional

KITCHIN DENTAL ABCESS DRAIN (K885231) - FDA 510(k) Clearance

Class I Dental device.

K885231 · Kitchin, Inc. · Dental device
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May 1989
Decision
147d
Days
Class 1
Risk

K885231 is an FDA 510(k) clearance for the KITCHIN DENTAL ABCESS DRAIN. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Kitchin, Inc. (Ravenna, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Kitchin, Inc. devices

Submission Details

510(k) Number K885231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date May 16, 1989
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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.