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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
Total temporomandibular joint prosthesis FDA UDI
Device Name
2.3 x 10 mm Self-Tapping Bone Screw FDA UDI
Model / Reference
61-2310 FDA UDI
Description
2.3 x 10 mm Self-Tapping Bone Screw FDA UDI

Identifiers

Primary DI / UDI-DI
07613327626803 FDA UDI
PMA Number
P980052 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization 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.

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 9e1f0df7-5ad4-498b-a6b6-1dc1d825f463 35 fields · synced Jun 6, 2026