Cleared Traditional

K924333 - THE DAVIS DISPOSABLE PROTECTIVE SPLINT

K924333 is an FDA 510(k) clearance for THE DAVIS DISPOSABLE PROTECTIVE SPLINT, manufactured by Ora-Gard, Inc.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K924333 · Ora-Gard, Inc. · Neurology device
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Apr 1993
Decision
239d
Days
Class 2
Risk

K924333 is an FDA 510(k) clearance for the THE DAVIS DISPOSABLE PROTECTIVE SPLINT. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Ora-Gard, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 239 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ora-Gard, Inc. devices

FDA 510(k) Submission Details - K924333

510(k) Number K924333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date April 23, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 148d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXL Device Classification - Class 2, Special Controls

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXL Block, Bite

All 15
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K924333.
UNIVERSAL BITE BLOCK
K960663 · B&B Medical Technologies, Inc. · May 1996
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
TUM-E-VAC BITE BLOCK
K921946 · Ethox Corp. · Dec 1992
OBERTO MOUTH PROP
K864962 · Medovations, Inc. · Feb 1987