ParaPost Fiber Lux

Basic Information

• Brand Name: ParaPost Fiber Lux
• Primary DI: D661600185691
• Version / Model: 60018569
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-11-28
• Public Version: 1
• Public Version Date: 2024-12-06
• Public Version Status: New
• Public Device Record Key: c11e3e3d-2ad6-438e-a76a-26d93bf6a71c

Device Description

ParaPost Fiber Lux Size 4

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: 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: Yes
• Has Manufacturing Date: Yes
• 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
ELR	Post, Root Canal	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38609	Root canal post, preformed	A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D661600185690	HIBCC
Secondary	00840016201851	GS1
Primary	D661600185691	HIBCC