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K Number
K960663
Device Name
UNIVERSAL BITE BLOCK
Manufacturer
B & B MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-05-17

(91 days)

Product Code
JXL
Regulation Number
882.5070
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.5070 Bite block.

(a)
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.(b)
Classification. Class II (performance standards).