Cleared Traditional

K960663 - UNIVERSAL BITE BLOCK

K960663 is an FDA 510(k) clearance for UNIVERSAL BITE BLOCK, manufactured by B&B Medical Technologies, Inc.. The device is a Class 2 Neurology device with product code JXL cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K960663 · B&B Medical Technologies, Inc. · Neurology device
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May 1996
Decision
91d
Days
Class 2
Risk

K960663 is an FDA 510(k) clearance for the UNIVERSAL BITE BLOCK. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 91 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K960663

510(k) Number K960663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1996
Decision Date May 17, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 149d · This submission: 91d
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 K960663.
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
K150518 · Dupaco, Inc. · Jun 2015
EPIGUARD
K050188 · Episafe Medical Devices, Ltd. · Apr 2005
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc. · Oct 1999
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
THE DAVIS DISPOSABLE PROTECTIVE SPLINT
K924333 · Ora-Gard, Inc. · Apr 1993