BioJVA

FDA UDI

Class I (US FDA UDI)

by Bio-Research Associates, Inc.

Identity

Trade Name: BioJVA FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Model / Reference: Headset FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003499931 FDA UDI
510(k) Number: K905657 FDA UDI
FDA Product Code: NFQ FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

BioJVA by Bio-Research Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K905657 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bio-Research Associates, Inc.

Sources (1)

FDA UDI 55d3bb14-400b-471e-a9d0-b7c5afb36930 34 fields · synced May 30, 2026