Patient-Fitted TMJ Reconstructive Prosthesis System

Basic Information

• Brand Name: Patient-Fitted TMJ Reconstructive Prosthesis System
• Primary DI: B004YYMMDDNNNNM0
• Version / Model: YYMMDDNNNNM
• Company Name: TMJ Solutions, Inc.
• Labeler DUNS: 035877922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-10
• Public Version: 1
• Public Version Date: 2021-11-18
• Public Version Status: New
• Public Device Record Key: 774452bc-4432-4de8-a9a4-2ef8704a8253

Device Description

Anatomical Bone Model

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZD	Joint, Temporomandibular, Implant	Dental	872.3940	3

GMDN Terms

Code	Name	Definition	Implantable	Status
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B004YYMMDDNNNNM0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P980052	007