Patient-Fitted TMJ Reconstructive Prosthesis System

Basic Information

• Brand Name: Patient-Fitted TMJ Reconstructive Prosthesis System
• Primary DI: B0046123080
• Version / Model: 61-2308
• Company Name: TMJ Solutions, Inc.
• Labeler DUNS: 035877922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-27
• Public Version: 6
• Public Version Date: 2022-04-19
• Public Version Status: Update
• Public Device Record Key: f3ac2c51-37fc-45be-961a-4e9aedcce04e

Device Description

Bone Screw 2.3mm x 8mm

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
36042	Total temporomandibular joint prosthesis	A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B0046123080	HIBCC

Customer Contacts

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