Tri-Nex

Basic Information

• Brand Name: Tri-Nex
• Primary DI: D768PANL35P0
• Version / Model: PA-NL-35P
• Catalog Number: PA-NL-35P
• Company Name: KEYSTONE DENTAL, INC.
• Labeler DUNS: 787471015
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-11
• Public Version: 5
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 421a650e-4d90-4da8-ba9f-0dfde3dc49c9
• Distribution End Date: 2019-04-26

Device Description

Temp Sleeve

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D768PANL35P0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Outer Diameter 3.5 - 6.0mm