Cleared Traditional

CONVENTIONAL PLASTIC DENTAL TRAYS (K841491) - FDA 510(k) Clearance

Class I Dental device.

K841491 · Buffalo Dental Mfg. Co., Inc. · Dental device
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Jul 1984
Decision
94d
Days
Class 1
Risk

K841491 is an FDA 510(k) clearance for the CONVENTIONAL PLASTIC DENTAL TRAYS. Classified as Tray, Impression, Preformed (product code EHY), Class I - General Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6880 - 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 Buffalo Dental Mfg. Co., Inc. devices

Submission Details

510(k) Number K841491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1984
Decision Date July 13, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHY Tray, Impression, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6880
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.