Universal Bite Block

FDA 510(k) K960663 · B&B Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK960663

Submission

Device name
Universal Bite Block
Applicant
B&B Medical Technologies, Inc.
Orangevale, CA, US
Received
February 16, 1996
Decision date
May 17, 1996
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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Questions and answers

When was Universal Bite Block cleared by the FDA?

Universal Bite Block (K960663) received a 510(k) decision of Substantially Equivalent on May 17, 1996, 91 days after the submission was received.

What is the product code of K960663?

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