CanalPro

Basic Information

• Brand Name: CanalPro
• Primary DI: D661600139940
• Version / Model: 60013994
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-21
• Public Version: 4
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 48d3fa27-b8c6-4b58-b32f-b1081860453a

Device Description

CanalPro CHX-Ultra 2%, 480 ml

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: 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
KJJ	Cleanser, Root Canal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34524	Dental tooth-cleaning solution	A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D661600139940	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082470	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius