TPC

Basic Information

• Brand Name: TPC
• Primary DI: D861ALED60N0
• Version / Model: ALED60N
• Catalog Number: ALED60N
• Company Name: TPC ADVANCE TECHNOLOGY, INC.
• Labeler DUNS: 968884275
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c0b3f71e-69ed-4ab7-90dd-a46d48df9745

Device Description

LED light cure

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
EBZ	Activator, Ultraviolet, For Polymerization	Dental	872.6070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35761	Dental laboratory curing unit	A mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D861ALED60N0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001719	000