Bite Block

FDA 510(k) K924304 · United States Endoscopy Group, Inc.

Substantially Equivalent

510(k) numberK924304

Submission

Device name
Bite Block
Applicant
United States Endoscopy Group, Inc.
Waite Hill, OH, US
Received
August 26, 1992
Decision date
April 6, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JXL – Block, Bite
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5070
Specialty
Neurology

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K172978SurgeoBiteJXL · Traditional Surgovations, LLC12/22/2017SE
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K050188EpiguardJXL · Traditional Episafe Medical Devices, Ltd.04/27/2005SE
K992269Ventil-A Oral ProtectorJXL · Traditional Somatics, Inc.10/25/1999SE
K960663Universal Bite BlockJXL · Traditional B&B Medical Technologies, Inc.05/17/1996SE
K954352Bite BlockJXL · Traditional United States Endoscopy Group, Inc.01/25/1996SE
K941856Premier Promax Bite GuardJXL · Traditional Premier Dental Products Co.04/05/1995SE
K924333The Davis Disposable Protective SplintJXL · Traditional Ora-Gard, Inc.04/23/1993SE

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Questions and answers

When was Bite Block cleared by the FDA?

Bite Block (K924304) received a 510(k) decision of Substantially Equivalent on April 6, 1993, 223 days after the submission was received.

What is the product code of K924304?

The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.