← Back to catalogue

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
Total temporomandibular joint prosthesis FDA UDI
Device Name
Left Fossa Component FDA UDI
Model / Reference
TYY-NNNNLF FDA UDI
Description
Left Fossa Component FDA UDI

Identifiers

Primary DI / UDI-DI
B004TYYNNNNLF0 FDA UDI
FDA Product Code
LZD FDA UDI
GMDN Term
Total temporomandibular joint prosthesis 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total temporomandibular joint prosthesis

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 Total temporomandibular joint prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
TMJ Solutions, LLC

Sources (1)

  • FDA UDI b2a927d8-10da-4e27-ab55-27f49f4db964 34 fields · synced May 30, 2026