Jackson Bite Blocks

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822018 ↗

FDA Product Code

JXL

Device Class

Class II

Regulation

21 CFR Part 882.5070

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K821709 Active Cleared 25 Jun 1982

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  FDA 510(k) K822278 Active Cleared 27 Aug 1982

See all devices from Kelleher Corp. →

• What is the intended use of Jackson Bite Blocks?

  Jackson Bite Blocks are designed for use in a neurological setting. The device functions as a block that is placed between a patient's teeth during clinical procedures.

• What is the regulatory classification of this device?

  Jackson Bite Blocks are classified as a class 2 medical device under regulation number 882.5070. The device received FDA 510k authorization under K-number K822018.

• Which medical specialty uses Jackson Bite Blocks?

  These bite blocks are categorized under the neurology medical specialty. They are specifically designed to meet the requirements of neurological clinical environments.