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Patient-Fitted TMJ Reconstructive Prosthesis System

FDA UDI

Class I (US FDA UDI)

by TMJ Solutions, LLC

Identity

Trade Name
Patient-Fitted TMJ Reconstructive Prosthesis System FDA UDI
Generic Name
Joint prosthesis implantation kit, reusable FDA UDI
Device Name
TMJ Driver Handle and Blade (Loaner) FDA UDI
Model / Reference
60-0010 FDA UDI
Description
TMJ Driver Handle and Blade (Loaner) FDA UDI

Identifiers

Primary DI / UDI-DI
B0046000100 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

Patient-Fitted TMJ Reconstructive Prosthesis System by TMJ Solutions, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TMJ Solutions, LLC

Sources (1)

  • FDA UDI 7ea18a7c-c9e8-45f9-9254-c8e7369e4763 34 fields · synced Jun 8, 2026