Cleared Traditional

K940785 - MOUTH PROPS

K940785 is an FDA 510(k) clearance for MOUTH PROPS, manufactured by Worldwide Dental, Inc.. The device is a Class 1 Dental device with product code EIF cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K940785

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.

EIF Device Classification - Class 1, General Controls

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.