Cleared Traditional

K940785 - MOUTH PROPS (FDA 510(k) Clearance)

Class I Dental device.

K940785 · Worldwide Dental, Inc. · Dental device
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Oct 1994
Decision
225d
Days
Class 1
Risk

K940785 is an FDA 510(k) clearance for the MOUTH PROPS. Classified as Accessories, Retractor, Dental (product code EIF), Class I - General Controls.

Submitted by Worldwide Dental, Inc. (Clearwater, US). The FDA issued a Cleared decision on October 5, 1994 after a review of 225 days - an extended review cycle.

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. 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 Worldwide Dental, Inc. devices

Submission Details

510(k) Number K940785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date October 05, 1994
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 127d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIF Accessories, Retractor, 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.