Cleared Traditional

K941349 - DENTAL TRAY

K941349 is an FDA 510(k) clearance for DENTAL TRAY, manufactured by Cush Medical Products. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K941349 · Cush Medical Products · Dental device
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Jul 1994
Decision
127d
Days
Class 1
Risk

K941349 is an FDA 510(k) clearance for the DENTAL TRAY. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Cush Medical Products devices

FDA 510(k) Submission Details - K941349

510(k) Number K941349 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 21, 1994
Decision Date July 26, 1994
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

Regulatory Peers - EIA Unit, Operative Dental

All 70
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