TRI-OR

Basic Information

• Brand Name: TRI-OR
• Primary DI: 07290110722258
• Version / Model: TRI-OR 1.8-10mm
• Catalog Number: TRI-OR 1.8-10
• Company Name: HI-TEC IMPLANTS LTD.
• Labeler DUNS: 600710917
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4ad4b1d9-bcbb-4add-b8d0-adb3e2f96b79

Device Description

DENTAL IMPLANT

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: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55850	Transmandibular implant	A sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. It is composed of a metal plate and transosteal pins or posts. The plate is held with retentive pins or screws fixed to the inferior border of the mandible, and supports the transosteal pins/posts that penetrate the full thickness of the mandible and project into the mouth in the inter-foraminal area.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110722258	GS1

Premarket Submissions

Submission Number	Supplement Number
K941575	000