T-Scan Novus

Basic Information

• Brand Name: T-Scan Novus
• Primary DI: B970DN1LVI0
• Version / Model: T-Scan System for LVI
• Catalog Number: DN1-LVI
• Company Name: Tekscan, Inc.
• Labeler DUNS: 178180246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-03
• Public Version: 1
• Public Version Date: 2020-11-11
• Public Version Status: New
• Public Device Record Key: 74d4cb84-72c0-4d4b-9c0b-14905ea0c8a4

Device Description

T-Scan Windows Software, 1 Novus Handpiece (USB Connection), 20 Large & 20 Small Sensors, 4 Touch-Free Sensor Supports, 1 Novus Handpiece Holder, 3 Adhesive Strips, 90 Day Free Customer Support, One Year Parts & Labor Warranty, Interactive Help File, Electronic Operations Manual.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B970DN1LVI0	HIBCC