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Patient-Fitted TMJ Reconstructive Prosthesis System

FDA UDI

Class III (US FDA UDI)

by TMJ Solutions, LLC

Identity

Trade Name
Patient-Fitted TMJ Reconstructive Prosthesis System FDA UDI
Generic Name
Custom-made organ/bone anatomy model FDA UDI
Device Name
Anatomical Bone Model, Accessory FDA UDI
Model / Reference
CHG024AM FDA UDI
Description
Anatomical Bone Model, Accessory FDA UDI

Identifiers

Primary DI / UDI-DI
07613327627763 FDA UDI
PMA Number
P980052 FDA UDI
FDA Product Code
LZD FDA UDI
GMDN Term
Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
872.3940 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Category: Custom-made organ/bone anatomy model

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

Similar devices

Also classified as Custom-made organ/bone anatomy model.

Cleared under the same submission

P980052 also covers:

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 f3d55055-dbd0-40fb-82cb-e662b45d29c9 35 fields · synced Jun 1, 2026