Cleared Traditional

UNIVERSAL BITE BLOCK (K960663) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all B&B Medical Technologies, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K960663.
PATI (Protector Against Tongue Injury)
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ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309 · Mecta Corporation · Jun 2021
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K954352 · United States Endoscopy Group, Inc. · Jan 1996
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K924304 · United States Endoscopy Group, Inc. · Apr 1993
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982